LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
Phase: NA
Conditions: Respiratory Complication
Sponsor: Medtronic - MITG

LIFEGUARD Clinical Investigation Plan  
 
 
CIP ID: MDT17026 
Version 2.0 
19 Jun 2019 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title LIFEGUARD Study – Continuous Respiratory
Monitoring on the General Ward 
Clinical Investigation Plan Identifier
MDT17026
Study Product Name
• Capnostream™20p and its accessories, 
including any sensor for SpO2 measurements and 
filter line for etCO2 sampling.  
• Vital Sync™ Virtual Patient Monitoring Platform 
• PM1000N-RR Nellcor™ Bedside Respiratory 
Patient Monitoring System and its accessories, 
including any sensor for SpO2 measurements. 
Sponsor
Covidien AG (an indirect, wholly owned subsidiary
of Medtronic plc represented in the European 
Union by Covidien Services Europe) 
Victor von Bruns Strasse 19 
8212 Neuhausen am Rheinfall 
Switzerland 
Authorized Representative Covidien Services Europe (an indirect, wholly 
owned subsidiary of Medtronic plc) 
Block 3090-3094 Lake Drive 
Citywest Business Park 
Dublin, 
Ireland  
Document Version
2.0 June 19, 2019
Principal Investigators
• Prof. Andreas Hoeft
Chair of Department of Anesthesiology and 
Intensive Care Medicine 
Universitätsklinikum Bonn (AöR) 
 Sigmund-Freud-Straße 25 
 D-53127 Bonn - Germany 
• Prof. Michael Sander  
Clinic Director of Department of Anesthesiology 
and Intensive Care Medicine, 
Universitätsklinikum Gießen und Marburg 
(UKGM) Baldingerstraße, 20043 Marburg - 
Germany 

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Confidentiality Statement
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 

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Table of Contents  
 
Table of Contents ...................................................................................................................... 3 
1. 
Glossary .............................................................................................................................. 6 
2. 
Synopsis ........................................................................................................................... 11 
3. 
Introduction ..................................................................................................................... 15 
3.1. Background ........................................................................................................................... 15 
3.2. Purpose ................................................................................................................................. 17 
4. 
Objectives and Endpoints ................................................................................................. 17 
4.1. Objectives ............................................................................................................................. 17 
4.1.1. 
Primary Objective and Endpoint ........................................................................................... 17 
4.1.2. 
Secondary Objectives and Endpoints .................................................................................... 17 
5. 
Study Design .................................................................................................................... 18 
5.1 Duration ................................................................................................................................ 21 
5.2 Rationale ............................................................................................................................... 21 
6. 
Product Description.......................................................................................................... 21 
6.1. Capnostream Monitor ............................................................................................................. 23 
6.2. Vital Sync™ ........................................................................................................................... 23 
6.3. End-tidal Carbon Dioxide (etCO2) Sampling Line....................................................................... 24 
6.4. NellcorTM Bedside SpO2 Patient Monitoring System ................................................................... 25 
6.5. Peripheral Oxygen Saturation (SpO2) Sensor ............................................................................ 26 
6.6. Packaging .............................................................................................................................. 26 
6.7. Intended Population ............................................................................................................... 27 
6.8. Equipment ............................................................................................................................. 27 
6.9. Product Use ........................................................................................................................... 27 
6.10. 
Product Training Requirements ......................................................................................... 27 
6.11. 
Product Receipt and Tracking ............................................................................................ 27 
6.12. 
Product Storage ............................................................................................................... 28 
6.13. 
Product Return ................................................................................................................. 28 
6.14. 
Product Accountability ...................................................................................................... 28 

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7. 
Selection of Patients ........................................................................................................ 28 
7.1 Study Population .................................................................................................................... 28 
7.2 Patient Enrollment ................................................................................................................. 28 
7.3 Inclusion Criteria .................................................................................................................... 29 
7.4 Exclusion Criteria ................................................................................................................... 29 
8. 
Study Procedures ............................................................................................................. 30 
8.1 Schedule of Events ................................................................................................................. 30 
8.2 Patient Screening ................................................................................................................... 32 
8.3 Prior and Concomitant Medications ......................................................................................... 32 
8.4 Patient Consent ..................................................................................................................... 32 
8.5 Enrollment ............................................................................................................................. 33 
8.6 Treatment Assignment ........................................................................................................... 33 
8.7 Monitoring Period ................................................................................................................... 33 
8.8 Study Exit .............................................................................................................................. 34 
8.9 Assessment of Safety ............................................................................................................. 35 
8.10 Recording Data ...................................................................................................................... 35 
8.11 Deviation Handling ................................................................................................................. 36 
8.12 Patient Withdrawal or Discontinuation ..................................................................................... 36 
9. 
Risks and Benefits ............................................................................................................ 37 
9.1 Potential Risks ....................................................................................................................... 37 
9.2 Potential Benefits ................................................................................................................... 37 
9.3 Risk-Benefit Rationale ............................................................................................................ 37 
10. 
Adverse Events and Device Deficiencies ....................................................................... 38 
10.1 Definitions/Classifications ....................................................................................................... 38 
10.2 Reporting of Adverse Events ................................................................................................... 39 
10.3 Patient deaths ....................................................................................................................... 42 
10.4 Complaint reporting ............................................................................................................... 42 
11. 
Clinical Event Committee............................................................................................... 42 
12. 
Statistical Design and Methods ..................................................................................... 42 
12.1 Sample size justification ......................................................................................................... 42 
12.2 Data analysis and reporting .................................................................................................... 43 

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12.3 Analysis of clinical data ........................................................................................................... 43 
13. 
Ethics ............................................................................................................................. 44 
13.1 Statement(s) of Compliance.................................................................................................... 44 
13.2 Ethics Committee ................................................................................................................... 44 
13.3 Regulatory Requirements / Competent Authorities ................................................................... 45 
13.4 Patient Compensation and Indemnification .............................................................................. 45 
14. 
Study Administration ..................................................................................................... 45 
14.1 Monitoring ............................................................................................................................. 45 
14.2 Data Management .................................................................................................................. 46 
14.2.1 Patient Data ............................................................................................................................. 46 
14.2.2 Device Data .............................................................................................................................. 46 
14.3 Direct Access to Source Data/Documents ................................................................................ 46 
14.3.1 
Accessibility of Investigation Site Staff and Study Materials ............................................. 46 
14.3.2 
Audits and Investigation Site Inspections .......................................................................... 47 
14.4 Confidentiality ........................................................................................................................ 47 
14.5 Liability ................................................................................................................................. 47 
14.6 CIP Amendments ................................................................................................................... 47 
14.7 Record Retention ................................................................................................................... 48 
14.7.1 
Investigator Records .......................................................................................................... 48 
14.7.2 
Sponsor Records ................................................................................................................ 48 
14.8 Publication and Use of Information ......................................................................................... 49 
14.9 Suspension or Early Termination ............................................................................................. 49 
15. 
References ..................................................................................................................... 51 
16. 
Appendices .................................................................................................................... 54 
Appendix A: List of Anticipated Adverse Events ............................................................................... 54 
Appendix B: Alarm Management Protocol ........................................................................................ 56 
Appendix C: List of Medications ...................................................................................................... 59 
Appendix D: American Society of Anesthesiologists Physical Status................................................... 60 
Appendix E: ARISCAT, POSPOM and NEWS scores calculation .......................................................... 61 
17. 
Version History .............................................................................................................. 66 

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1. Glossary 
Term 
Abbreviation 
Definition 
Adverse Event 
AE 
Any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in patients, 
users or other persons, whether or not related to 
the investigational medical device. 
NOTE 1 This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2 This definition includes events related to the 
procedures involved. 
NOTE 3 For users or other persons, this definition is restricted 
to events related to investigational medical devices.
Adverse Device Effect 
ADE 
Adverse event related to the use of an 
investigational medical device. 
NOTE 1 This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
NOTE 2 This definition includes any event resulting from use 
error or from intentional misuse of the investigational 
medical device.
Admit, Discharge, 
Transfer  
ADT  
Software application used by healthcare facilities to
track patients from the point of arrival at a hospital
until departure by transfer, discharge, or death. 
American Society of 
Anesthesiologists 
physical status 
classification system   
ASA PS 
A surgical risk classification scale based upon health 
status assessment with range of ASA I - ASA VI. 
Assess Respiratory 
Risk in Surgical 
Patients in Catalonia 
Score  
ARISCAT 
Score  
ARISCAT Score is an accurate risk score for 
predicting high or intermediate risk for 
postoperative pulmonary complications in patients 
undergoing surgery, calculated based on 
preoperative data such as on patient's age, 
preoperative SpO2, respiratory infection, anemia, 
surgery type and duration.  
Capnography  
CO2 
monitoring  
A non-invasive method for monitoring the level of 
carbon dioxide in exhaled breath (etCO2). 

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Term 
Abbreviation 
Definition 
Clinical Investigation 
Plan 
CIP 
The present document describing LIFEGUARD Study 
Protocol. 
Code Blue  
Code Blue  
An emergency situation in which a patient is in 
cardiopulmonary arrest, requiring a Rapid Response 
Team (see definition) to rush to the specific 
location and begin immediate resuscitative efforts. 
Electronic Medical 
Records 
EMR 
A digital version of medical record that contains all 
of a patient's medical history in one practice. 
Early Warning Score 
EWS 
Physiologic track and trigger systems, based on 
patients’ vital signs, used to monitor adult patients 
in acute hospital settings to prevent Adverse 
Events. 
Electronic Case Report 
Forms 
eCRF 
Forms where the clinical data are collected. eCRF is 
the electronic version of case report forms. 
Ethical Committee  
EC 
Any board, committee, or other group formally 
designated by an institution to review, to approve 
the initiation of, and to conduct periodic review of, 
biomedical research involving human patients. The 
primary purpose of such review is to assure the 
protection of the rights and welfare of the human 
patients.  
End Tidal CO2 
etCO2 
The numeric partial pressure of the maximum value 
of carbon dioxide in the exhaled breath over the 
last 20 seconds. The etCO2 numeric value is 
updated once a second.  
Intensive Care Unit 
ICU 
Acute care with 24 hour coverage. Patients may be 
directly transferred from the OR to the ICU or via 
the PACU.  
Integrated Pulmonary 
Index™ 
IPI 
The Integrated Pulmonary Index (IPI) is a composite 
index of etCO2, SpO2, RR and PR that is intended to 
indicate changes in physiological status as indicated 
by the monitored variables and cleared by FDA 
(K082268) in 2009. 
Preoperative Score to 
Predict Postoperative 
Mortality Score 
POSPOM 
Score  
POSPOM Score is an accurate risk score for 
predicting in-hospital mortality in patients 
undergoing surgery, calculated based on 
preoperative data such as on patient's age, planned 

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Term 
Abbreviation 
Definition 
surgery and presence of additional diseases or 
disorders.  
Pulse Rate 
PR 
Pulsatile cycle in beats per minute via pulse 
oximeter technology. 
Pulse Oximetry 
SpO2 
Depends on pulsatile blood flow and measures only 
the oxyhemoglobin in arterial blood as it leaves the 
heart. 
Rapid Response Team 
RRT 
A team of health care providers that responds to 
hospitalized patients with early signs of 
deterioration on non-intensive care units to 
prevent respiratory or cardiac arrest. 
Respiratory 
Compromise 
RC 
Respiratory compromise consists of respiratory 
insufficiency, compromise, distress, arrest, and 
failure. Respiratory Compromise is a state in which 
there is a high likelihood of decompensation into 
respiratory insufficiency, respiratory failure or 
death, but in which specific interventions 
(enhanced monitoring and/or therapies) might 
prevent or mitigate decompensation. 
Respiratory 
Depression 
RD 
Respiratory depression is a decrease in the 
effectiveness of an individual’s ventilatory function 
generally defined as deviation of respiratory rate, 
pulse oximetry value or arterial carbon dioxide 
tension from an arbitrary threshold1. 
Remote Data Capture 
RDC 
An interface that allows site users at sites to enter 
data directly into the study database via a web 
interface. RDC is an example of Electronic Data 
Capture method or EDC. 
Respiration Rate  
 
RR 
The count of breaths per minute based upon the 
carbon dioxide cycle as measured by capnography.  
Serious Adverse 
Device Effect 
SADE 
Adverse device effect that has resulted in any of 
the consequences characteristic of a Serious 
Adverse Event. 
Serious Adverse Event 
SAE 
An adverse event that  
a) led to death, 

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Term 
Abbreviation 
Definition 
b) led to serious deterioration in the health of 
the patient, that either resulted in  
c) a life-threatening illness or injury, or 
d) a permanent impairment of a body structure 
or a body function, or 
e) in-patient or prolonged hospitalization, or  
f) medical or surgical intervention to prevent 
life-threatening illness or injury or permanent 
impairment to a body structure or a body 
function, 
g) led to fetal distress, fetal death or a congenital 
abnormality or birth defect.   
Vital Sync™ 
VS  
Vital Sync™ is the brand under which all Integrated 
Patient Intelligence related products are sold. 
Included in the brand are the Vital Sync Informatics 
Manager (VSIM) and the Vital Sync Virtual Patient 
Monitoring Platform (VPMP). 
Vital Sync™ 
Informatics Manager  
 
VSIM 
Is a software solution that resides on a hospitals 
network that collects, organizes, redistributes, and 
stores medical device data and device diagnostic 
information from supported devices to the HIPPA 
compliant hospital Electronic Medical Record (EMR) 
and Clinical Information System (CIS). 
Vital Sync™ Virtual 
Patient Monitoring 
Platform 
Vital Sync™ 
VPMP 
A remote continuous patient monitoring software 
solution allowing EMR, ADT and annunciation 
connectivity. It allows clinicians to remotely view 
patient information from multiple device categories 
(ventilators, capnography monitors, pulse 
oximeters, depth of consciousness monitors and 
regional oximetry) on any web-enabled device 
(smartphones, tablets, desktops, central nurse 
station). 
Vulnerable patient 
 
Individual whose willingness to volunteer in a 
clinical investigation could be unduly influenced by 
the expectation, whether justified or not, of 
benefits associated with participation or of 
retaliatory response from senior members of a 
hierarchy in case of refusal to participate. 

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Term 
Abbreviation 
Definition 
EXAMPLE: Individuals with lack of or loss of 
autonomy due to immaturity or through mental 
disability, persons in nursing homes, children, 
impoverished persons, patients in emergency 
situations, ethnic minority groups, homeless 
persons, nomads, refugees, and those incapable of 
giving informed consent. Other vulnerable patients 
include, for example, members of a group with a 
hierarchical structure such as university students, 
subordinate hospital and laboratory personnel, 
employees of the sponsor, members of the armed 
forces, and persons kept in detention. 
This might also include pregnant, parturient or 
breastfeeding patients and patients hospitalized 
without their consent. 
 
 

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2. Synopsis 
Title 
LIFEGUARD Study – Continuous Respiratory Monitoring on the 
General Ward 
Clinical Study Type 
Prospective, interventional, post-market pilot study 
Product Name 
• Capnostream™20p and its accessories, including any sensor for 
SpO2 measurements and filter line for etCO2 sampling.  
• Vital Sync™ Virtual Patient Monitoring Platform 
• PM1000N-RR Nellcor™ Bedside Respiratory Patient Monitoring 
System and its accessories, including any sensor for SpO2 
measurements. 
Sponsor  
Covidien AG (an indirect, wholly owned subsidiary of Medtronic plc 
represented in the European Union by Covidien Services Europe) 
Victor von Bruns Strasse 19 
8212 Neuhausen am Rheinfall 
Switzerland 
Authorized Representative 
Covidien Services Europe (an indirect, wholly owned subsidiary of 
Medtronic plc) 
Block 3090-3094, 
Citywest Business Park,  
Dublin, 
Ireland 
Investigation Purpose 
The purpose of this study is to quantify the incidence and the severity 
of postoperative RC markers on high risk postsurgical patients on a 
general ward.  
Product Status 
Products used are commercially available (CE-Marked) and used 
within intended use in the participating countries. 
Primary Objective(s) 
The primary objective of this study is to quantify the incidence of RC 
markers in high risk postsurgical patients, using a system comprised of 
two continuous monitoring devices, connected to a remote 
monitoring platform.  
The occurrence of at least one of the following RC markers will be 
considered as primary endpoint for patients monitored by 
Capnostream 20p during both study Phases: 
1. SpO2 ≤ 90% for ≥ 3 minutes. 
2. RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. 
3. etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes. 
4. Apnea episode lasting > 30 seconds. 

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The occurrence of at least one of the following RC markers will be 
considered as primary endpoint for patients monitored by PM1000N-
RR during both study Phases: 
1. SpO2 ≤ 90% for ≥ 3 minutes. 
2. RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. 
Secondary Objective(s) 
The study secondary objectives are the following: 
 
To compare the two study Phases in terms of primary 
endpoint incidence. 
 
To compare the two study Phases in terms of respiratory AEs 
and SAE incidence, numbers of ICU transfers and related 
length of stay, Code blues and RRT responses. 
 
To evaluate the impact of introducing continuous monitoring 
devices connected to a remote monitoring platform, on the 
clinical workflow, defined as the rate of clinical early 
interventions performed by nurse staff to prevent a potential 
AE (e.g. patient stimulation, Jaw thrust maneuver, oxygen 
administration started or increased, medication change, etc.). 
 
To evaluate the impact of introducing continuous monitoring 
devices connected to a remote monitoring platform on 
clinical staff’s workflow, defined as clinical staff’s satisfaction 
related to the monitoring system. 
 
To characterize the predictive values of etCO2, RR, SpO2, 
plethysmography-derived RR, IPI2 and EWS in respect to 
respiratory AEs and other SAE.  
Related secondary endpoints are: 
 
Incidence of RC markers recorded during each Phase. 
 
Incidence of respiratory AEs and SAE, number of ICU transfers 
and related length of stay, Code blues and RRT responses 
recorded in the two study Phases. 
 
Average rate of early interventions for patient will be 
calculated in both study Phases. In Phase I there should only 
be non- alarm-triggered interventions, as in clinical practice, 
while in Phase II there should be two sub-groups of clinical 
early interventions: alarm-triggered and non- alarm-triggered.
 
Clinical staff’s satisfaction related to each of the monitoring 
systems introduction in their current workflow will be 
evaluated through a survey performed at the end of the 
study. 

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 
Sensitivity and specificity of each monitored parameter in 
predicting and identifying respiratory AEs and SAE will be 
calculated.  
Study Design 
LIFEGUARD is a prospective, two-center, two-phase pilot study. 
The study population consists of post-surgical patients of adult age on 
the hospital ward at high risk of developing respiratory and 
cardiovascular events. 
During the study Phase I, 70 patients will be 1:1 randomly allocated to 
Capnostream 20p monitoring system or to PM1000N-RR pulse 
oximeter monitoring system. In this first phase the alarms of both 
devices will be silenced and the screen information blinded, to 
establish a baseline for the incidence of respiratory events in 
continuously monitored high risk patients. After Phase I and before 
starting Phase II, each participating site will have a minimum of a 1-
month period for familiarization with the unblinded devices, based on 
a pre-defined hospital protocol for alarm management and escalation 
policy. 
During the study Phase II, an additional 140 patients will be 1:1 
randomly allocated to Capnostream 20p or to PM1000N-RR 
monitoring but the screen information will be visible at the bedside 
and through the Vital Sync™ remote patient monitoring system.  The 
nursing staff will respond to device alarms based on a pre-defined 
alarm management policy. 
Sample Size 
Approximately 210 patients will be enrolled in 2 European centers.  
Each participating center may involve one or more wards in the study, 
based on its distribution of high-risk patients that may benefit from 
monitoring. 
 
Inclusion/Exclusion Criteria 
The following criteria must be met for inclusion in the study: 
1. Non-cardiac post-surgical patients at high risk of developing 
respiratory and cardiovascular events based on both 
ARISCAT3 and POSPOM4 scores on the hospital ward. In 
particular, to be enrolled a patient must have: 
POSPOM score ≥ 24 (> 3 times the mortality average risk)  
OR 
ARISCAT score ≥ 26 (High or intermediate risk for 
postoperative pulmonary complications). 
2. Adult age (≥18 year old). 
3. Patient is able and willing to give informed consent. 
Exclusion criteria (any of the list below): 

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1. Expected ward length of stay ≤24 hours.
2. Post-surgical patients with American Society of 
Anesthesiologists physical status (ASA PS) V or higher. 
3. Ventilated or intubated patients on the ward. 
4. Patient is unwilling or unable to comply fully with study 
procedures (including non-toleration of the capnography 
cannula or skin contact allergies to medical grade adhesives) 
due to any disease condition which can raise doubt about 
compliance and influencing the study outcome.  
5. Patient is a member of a vulnerable population, including 
legal incapacity or evidence that a patient cannot understand 
the purpose and risks of the study, regardless of authorized 
representative support. 
6.  Patient is participating in another potentially confounding 
drug or device clinical study. 
Study Procedures and 
Assessments 
Screening will be conducted to identify potential patients who will be 
admitted to the wards.  
If the patient is potentially eligible, fully informed and willing to 
consider participation, written informed consent must be obtained. A 
review of patient medical files by the investigator is required to 
determine preliminary eligibility according to patient inclusion and 
exclusion criteria. Patients are considered a screen failure if 
inclusion/exclusion criteria are not met prior to commencement of 
monitoring on the hospital ward. 
During both study phases, each patient will be monitored for a 
minimum of 24 hours and up to patient’s mobilization or for a 
maximum of 72 hours.  
The continuous monitoring data will be recorded for subsequent 
analysis in conjunction with patient eCRFs. A regular check during the 
monitoring period should be completed to ensure the etCO2 filter line 
and SpO2 sensors are appropriately fitted on the patient. 
A survey will be conducted amongst the participating clinical staff to 
assess levels of their satisfaction and patient compliance with the 
different monitoring technologies and the overall feasibility of 
continuous respiratory monitoring in a general ward setting. 
Safety Assessments 
Occurrence of any AE with an underlying respiratory cause, SAE or 
Device Deficiencies will be documented. 
 Statistics 
The sample size calculation is based on the primary endpoint and it 
was estimated using data from previous studies with a precision-
based calculation.   

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The analysis of primary objective will be based on the proportion of 
patients with at least one RC marker; it will be reported together with 
their 95% confidence intervals and separately for each arm and phase 
of the study. When comparison of clinical primary outcomes is 
conducted the propensity score methods could be used to control for 
biases and confounding which may occur due to the nature of this 
study. For all secondary outcomes the logistic regression model will 
be used to check potential predictors.  
Bivariate odds ratios (ORs) and 95% confidence intervals (95% CIs) will 
be estimated for each predictor. A multivariate logistic regression 
model will be performed according to univariate model’s results. 
Other secondary outcomes will be performed using sensitivity and 
specificity analysis. 
3. Introduction  
3.1. Background  
Early postsurgical period is associated with high incidence of postoperative pulmonary complications, 
including pneumonia, aspiration pneumonitis, respiratory failure, re-intubation within 48h, weaning 
failure, pleural effusion, atelectasis, bronchospasm, and pneumothorax5. The reported incidence rates 
range from 2 to 40% depending on context5. Estimates suggest that more than 1 million postoperative 
pulmonary complications occur annually in the United States, with 46, 200 related deaths and 4.8 
million additional hospitalization days3,6. ISOS and EUSOS studies showed that in Europe the incidence of 
postsurgical critical events and in-hospital mortality are also significant7,8. 
Patients with one or more pulmonary complications, even mild, have up to 48% increased early 
postoperative mortality and up to 91% increased intensive care unit (ICU) admission3,5,6. In the case of 
postoperative pulmonary complications, a mean increase of hospital length of stay of approximately 8 
days and a cost of surgery from 2 to 12-fold higher were also reported5. 
The most frequent severe postoperative respiratory complication is respiratory failure, defined as 
unexpected tracheal re-intubation, need for postoperative mechanical ventilation, postoperative acute 
lung injury and acute respiratory distress syndrome, with a reported incidence ranging between 0.2 and 
3.4%9. Main predictive risk factors for hypoventilatory respiratory failure are obesity, breathing disorder 
conditions (e.g., obstructive sleep apnea), and postsurgical use of anesthetic and analgesic 
medications10. Respiratory failure is reported to contribute to increased hospital stay, cost of care and 
30-days readmission rate11–13. 
Different scores have been developed to try predicting postoperative respiratory complications and 
mortality3,14–16. Main reported predictors include (but are not limited to) older age, preoperative low 
SpO2, previous respiratory infections, preoperative anemia, intrathoracic/upper abdominal surgical 
incision, concomitant cardiac disease, diabetes, surgery duration and emergency procedure3.  

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Postoperative hypoxemia it is a strong indicator of patient instability, compromises wound healing and 
promotes other serious complications, including brain dysfunction, dysrhythmias and myocardial 
ischemia17. Prolonged hypoxemic episodes have been reported to be common in hospitalized patients 
recovering from non-cardiac surgery: up to 37% of patients had at least one episode of oxygen 
saturation < 90% lasting more than one hour while 3% had saturations <80% for at least 30 minutes17. 
Postsurgical patients at-risk of developing cardiopulmonary complications could benefit from both 
preventive interventions and more intensive postsurgical monitoring5. Up to 84% of in-hospital 
cardiopulmonary arrest events are preceded by prolonged periods of physiological and clinical 
instability18,19. Early intervention of clinically unstable patients by a medical emergency team 
significantly reduces the incidence of, and mortality from, unexpected cardiac arrest in hospital20. A 
significant decrease in the number of cases of respiratory failure, stroke, severe sepsis, and acute renal 
failure was also shown after the implementation of a medical emergency team in an Australian study21. 
In 2007, the UK National Institute for Health and Clinical Excellence recommended the use of 
physiological track and trigger systems to monitor adult patients in acute hospital settings: these 
systems, also known as Early Warning Scores (EWS), are based on the monitoring of patients' basic 
physiological observations such as pulse rate, SpO2, blood pressure, respiration rate, temperature and 
conscious level and are used to identify patients at risk of respiratory failure, cardiac arrest and 
death22,23. A systematic review has reported that EWS have a strong predictive value for the occurrence 
of cardiac arrest and death within 48 hours of measurement24. EWS has been demonstrated to be 
effective in predicting clinical deterioration that may lead to a cardiac arrest also in patients in wards 
that are poorly equipped to detect rapid patient deterioration25. National EWS (NEWS), based upon 
common vital signs such as temperature, respiratory rate, heart rate, systolic blood pressure, nursing 
assessments of consciousness level of the patient, SpO2 and use of supplemental oxygen  is one of the 
most frequently utilized24.  
Respiratory compromise (RC) is a state in which there is a high likelihood of decompensation into 
respiratory depression, respiratory failure or death, but in which specific interventions (enhanced 
monitoring and/or therapies) might prevent or mitigate decompensation26. Patients with RC have up to 
a two-fold increase in mortality following delayed medical emergency team activation27. Detecting a 
patient’s declining RC status before progression to respiratory depression in patients continuously 
monitored in the general ward could allow earlier intervention, thus potentially decreasing adverse 
outcomes28.  
Due to possibly improved patient safety, continuous SpO2 and capnography monitoring combined with 
automated decision support tools to determine potential or established patient critical illness are 
starting to have an important role also outside ICU29. Current standard of care for respiratory monitoring 
of high risk hospital ward patients, such as those receiving opioid therapy, is intermittent 
documentation of SpO2 value (e.g. spot checks performed at 4 to 6 hours intervals)1,17. Respiratory rate 
(RR) is often determined by clinician assessment though manual inaccurate respiration counts28.  
Growing evidence supports the use of capnography for earlier and more reliable warnings of potential 
RC in postoperative patients in the general ward, compared with pulse oximetry30–33.  Capnography 
monitoring has also been associated with in-hospital mortality in emergency department patients with 
cardiac arrest and suspected sepsis across a range of disease severity34,35. 

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There are no data on the real incidence and severity of potential RC markers and their correlation with 
cardiopulmonary or other complications in European postsurgical patients. A pilot study on this topic 
could be useful to collect information on the utility of continuous SpO2 and capnography monitoring in 
this setting and to develop future clinical evidence. This study may also provide the data needed to 
evaluate certain health-economic outcomes associated with introduction of continuous monitoring in 
the general ward setting. 
3.2. Purpose 
The main purpose of this study is to quantify the incidence and the severity of postoperative RC markers 
on high risk postsurgical patients on a general ward. 
4. Objectives and Endpoints 
4.1. Objectives 
4.1.1. Primary Objective and Endpoint 
The primary objective of this study is to quantify the incidence of RC markers in high risk postsurgical 
patients, using a system comprised of two continuous monitoring devices, connected to a remote 
monitoring platform.  
The occurrence of at least one of the following RC markers will be considered as primary endpoint for 
patients monitored by Capnostream 20p during both study Phases: 
1. SpO2 ≤ 90% for ≥ 3 minutes. 
2. RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. 
3. etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes. 
4. Apnea episode lasting > 30 seconds. 
 
The occurrence of at least one of the following RC markers will be considered as primary endpoint for 
patients monitored by PM1000N-RR during both study Phases: 
1. SpO2 ≤ 90% for ≥ 3 minutes. 
2. RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. 
4.1.2. 
Secondary Objectives and Endpoints 
The study secondary objectives are the followings: 
1. To compare the two study Phases (see Section 5) in terms of primary endpoint incidence. 
2. To compare the two study Phases in terms of respiratory AEs and SAE incidence, number of ICU 
transfers and related length of stay, Code blues and RRT responses. 
3. To evaluate the impact of introducing continuous monitoring devices connected to a remote 
monitoring platform on the clinical workflow, defined as the rate of clinical early interventions 
performed by nursing staff to prevent a potential AE (e.g. patient stimulation, Jaw thrust 
maneuver, oxygen administration started or increased, medication change, etc.).  

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4. To evaluate the impact of introducing continuous monitoring devices connected to a remote 
monitoring platform on clinical staff workflow, defined as clinical staffs’ satisfaction related to 
the monitoring system. 
5. To characterize the predictive values of etCO2, RR, SpO2, plethysmography-derived RR, IPI2 and 
EWS in respect to respiratory AEs and other SAE.  
 
Related secondary endpoints are: 
1. Incidence of RC markers recorded by the monitoring system during each Phase. 
2. Incidence of respiratory AEs and SAE, number of ICU transfers and related length of stay, Code 
blues and RRT responses recorded in the two study Phases. 
3. Average rate of early interventions for patient will be calculated in both study Phases. In 
Phase I there should only be non- alarm-triggered interventions, as in clinical practice, while in 
Phase II there should be two sub-groups of clinical early interventions: alarm-triggered and 
non- alarm-triggered. 
4. Clinical staff’s satisfaction related to the monitoring system’s introduction in their current 
workflow will be evaluated through a survey performed at the end of the study. 
5. Sensitivity and specificity of each monitored parameter in predicting and identifying 
respiratory AEs and SAE will be calculated. EWS will be the only parameter not automatically 
collected by the monitoring system but manually collected. 
5. Study Design  
LIFEGUARD is a prospective, post-market interventional, pilot study. Approximately 210 patients will be 
enrolled in two European centers. 
The study will consist of two phases. During both phases the patients will be 1:1 randomly allocated to 
Capnostream20p or to PM1000N-RR monitoring. The Capnostream 20p device provides data on etCO2, 
RR, SpO2, PR and IPI through an oral nasal cannula and a finger sensor, while PM1000N-RR provides 
SpO2, PR and RR derived from plethysmography through a single finger sensor. The aim of the random 
allocation is to have similar patient populations receiving monitoring with the two different devices. 
During the study Phase I, 70 patients will be enrolled and the alarms of both devices will be silenced and 
the screen information blinded, to establish the incidence of respiratory events, as is the current clinical 
practice in which continuous monitoring is not employed. After Phase I and before the start of study 
Phase II, each participating site will have a minimum of one month to familiarize themselves with the 
unblinded device, using a pre-defined hospital protocol for alarm management and escalation policy. 
During the study Phase II, an additional 140 patients will be enrolled; but in this phase the screen 
information will be available, and the nursing staff will be instructed to respond to both devices’ alarms 
based on a pre-defined hospital protocol. 
During both phases, each patient will be monitored for a minimum of 24 hours and up to patient’s full 
mobilization or for a maximum of 72 hours. At the end of the monitoring period the patient will 
complete the study and will continue to be treated according to standard clinical practice. Figure 1 
reports the study Flow-Chart. 

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A survey will be conducted at the end of the study amongst the participating physicians and nurses to 
assess levels of their satisfaction and patient compliance with the two different monitoring technologies 
and the overall feasibility of continuous respiratory monitoring in a general ward setting.  
Capnography and pulse oximetry monitoring device data will be collected as well as clinical data related 
to respiratory compromise. Patients will be monitored per standard of care.  
Enrollment at any single site will be limited to 50% (approximately 105 patients) to ensure poolability of 
the data across sites and reduce potential bias. Additional methods incorporated to minimize potential 
bias include the following: 
 
Systematic identification of potential patients via screening; 
 
Standard procedures and data collection requirements with a common electronic database for 
all sites; 
 
Random allocation to monitoring device. 
 
Foreseeable factors that may compromise the outcome of the study include lack of enrollment or the 
lack of RC events. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1. Study Flow-chart. 
  
 
Eligibility assessment and Informed Consent Signature 
(n= 70) 
Patients monitored for 24-72 hours, clinical 
interventions and adverse events collected 
Capnostream 20p
(n=35) 
PM1000N
(n=35) 
Phase 1: 
alarms silenced and device screens blinded  
Eligibility assessment and Informed Consent Signature 
(n= 140) 
Patients monitored for 24-72 hours, clinical 
interventions and adverse events collected 
Capnostream 20p
(n=70) 
PM1000N
(n=70) 
Phase 2: 
alarms enabled and device screens visible 
  One-month minimum period for unblinded device familiarization

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5.1 
Duration 
Each patient will be in the study for a maximum period of 72 hours. 
Each participating site may involve one or more wards, based on its distribution of surgical high-risk 
patients. The study is expected to last approximately one year. 
5.2 
Rationale  
There are few data in the literature on the incidence of RC in high risk surgical patients continuously 
monitored on a general ward in Europe. This pilot study will collect data on a high number of patients 
monitored by capnographic and/or SpO2 monitoring, thus allowing quantification of the incidence of 
respiratory markers and their correlation with cardiopulmonary or other complications in clinical 
practice and the related clinical and workflow impact. 
The study will also allow evaluation of two different monitoring devices coupled with a remote patient 
monitoring system in terms of sensitivity and patients’ compliance. 
 
6.  Product Description 
All devices used in this study are commercially available (CE-Marked) and used within intended use in 
Europe. The Instruction for Use (IFU) manual is provided with the product in local country language. 
The Capnostream monitoring system includes a capnograph/pulse oximeter monitor, sampling line for 
end tidal carbon dioxide (etCO2), and pulse oximetry sensor for measuring the peripheral oxygen 
saturation of arterial hemoglobin (SpO2). 
Table 1 provides a list of commercially available products that may be used in the study. 

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Table 1. Medtronic Market-Released Devices and Accessory Components 
Model or Version 
Product 
Manufacturer 
 
CS08651-02 
Capnostream™ 20p Portable Bedside Monitor 
Capnograph/Pulse Oximeter 
Oridion Medical 
Version 1.1 
Capnostream Software  
 
Vital Sync™ 2.4 or 
future CE-marked 
available versions 
Vital Sync™ Virtual Patient Monitoring 
Platform  
Medtronic  
Smart CapnoLine H 
Plus 
Smart CapnoLine H 
CapnoLine H 
CapnoLine H 02 
Smart CapnoLine Plus  
Smart CapnoLine 
O2/CO2 Nasal FilterLine 
etCO2 Sampling Line for Microstream™ –
enabled capnography monitors (mono use) 
Oridion Medical 
PM1000N-RR  
Nellcor™ Bedside Respiratory Patient 
Monitoring System Pulse Oximeter, with 
Nellcor™ Respiration Rate (RR) 
parameter; intended for the continuous, 
non-invasive monitoring of respiration 
rate. 
Covidien llc. 
OxiMax Max-A 
OxiMax Max-AL 
OxiMax MaxN 
MaxFast 
SoftCare 
Nellcor™ SpO2 Sensor (mono use) 
Covidien llc. 
 
Additional Accessories 
Roll Stand Assembly 
Vesa mounting plate 
Manfrotto clamp 
Power Supply kit (Main Electrical 
Power Cord with AC adapter) 
Battery Pack 
Extra battery / charger 
3.15 Amp Type F fuses 
FilterLine Starter Kit 
Sensor extension cables (4, 8, or 
10 feet) 
SpO2 Sensor Pack 
 

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6.1. Capnostream Monitor 
The Capnostream monitor and its accessories provide continuous, non-invasive measurement and 
monitoring of: 
 
End-tidal carbon dioxide (etCO2) - level of carbon dioxide in exhaled breath. 
 
Respiratory rate (RR) – breaths per minute. 
 
Peripheral oxygen saturation of arterial hemoglobin (SpO2) 
 
Pulse rate (PR) – pulsatile cycle in beats per minute via pulse oximeter technology 
The device also provides an Integrated Pulmonary Index™ (henceforth referred to as IPI) value, which is 
a numerical value that integrates four major parameters measured by Capnostream in order to provide 
a simple indication of the patient’s ventilatory status. The integrated parameters are etCO2, RR, SpO2, 
and PR. Only these four parameters are used to calculate IPI; other parameters are not taken into 
account. 
Figure 2. Capnostream 20p Portable Bedside Monitor 
 
 
 
 
 
 
 
 
 
 
6.2. Vital Sync™ 
The Medtronic Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is an FDA cleared 
and CE marked medical device. The Vital SyncTM Informatics Manager is the software that is intended to 
route and store medical device data and device diagnostic information from supported devices to the 
Electronic Medical Record (EMR) and Clinical Information System (CIS). The Vital SyncTM Virtual Patient 
Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and 
alarms routed through the Vital SyncTM Informatics Manager for supported devices.  The Capnostream 
20p and PM1000N-RR are supported devices on this system.  Patient information, generated during 

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Capnography and Pulse-Oximetry monitoring is transmitted wirelessly from the bedside devices to the 
hospital’s server. The Vital Sync™ software, which can reside on hospital’s server, takes this information 
and makes it viewable on any web-enabled device on the hospital network including a workstation or a 
Microsoft Surface tablet in case of nurse mobility. The information is formatted into HL7 protocol and 
written into the hospital EMR. HL7 protocol includes Electronic Medical Records, Alarm forwarding and 
Clinical Reports. The EMR integration feature of Vital Sync™ software will not be used in this study. No 
information can therefore be retrieved from the hospital EMR by the software. Patient data required for 
EWS calculation will be manually inputted to allow a retrospective analysis. 
For the purpose of the clinical study, the CE marked Vital Sync™ Version 2.4 or future CE marked 
versions will be installed at the 2 sites using a dedicated server computer to be provided either by the 
site themselves, or by Medtronic. 
 
Figure 3. Vital Sync™ VPMP  
 
6.3. End-tidal Carbon Dioxide (etCO2) Sampling Line 
A sample of the exhaled gases are delivered from the patient (via a cannula) into the monitor for etCO2 
measurement. The etCO2 sample line (also referred to as a filter line) is a disposable single use sampling 
line. Each study patient will be connected to the Capnostream monitor with an etCO2 sampling line.  
Supplemental oxygen may also be delivered through the sampling line, as needed. Any supplemental 
oxygen, up to 5 lit/min, will be delivered per usual clinical practice. The supplemental oxygen is not 
provided through the monitor. 
 
 
 
 

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Figure 4. etCO2 Sampling Line 
 
 
6.4. NellcorTM Bedside SpO2 Patient Monitoring System 
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for 
continuous non-invasive monitoring of: 
 
Peripheral oxygen saturation of arterial hemoglobin (SpO2) 
 
Pulse rate (PR) – pulsatile cycle in beats per minute via pulse oximeter technology 
 
Respiratory rate (RR) – plethysmography-derived 
If the monitoring system detects an alarm condition, it provides both visual and audible alarms. 
 

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Figure 5. Nellcor™ Bedside Respiratory Patient Monitoring System 
  
6.5. Peripheral Oxygen Saturation (SpO2) Sensor 
Pulse oximetry is a non-invasive method of measuring the amount of hemoglobin saturated with oxygen 
or SpO2.  Light emitting diodes (LEDs) emit red and infrared light. Changes in light absorption during the 
pulsatile cycle determine the SpO2. 
The oxygen transducers (sensors) are available as a reusable or a disposable single use sensor. 
Each study patient will be connected to the Nellcor or Capnostream monitor with a non-invasive SpO2 
disposable sensor applied to a finger (index finger preferred). 
Figure 6. SpO2 Sensor 
 
 
6.6. Packaging 
The devices used are all CE-Marked and will be provided with their standard packaging. Labelling of all the 
devices will be in local language. 

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6.7. Intended Population 
The Capnostream™ 20p combined capnograph/pulse oximeter monitor and its accessories are intended 
to provide professionally trained health care providers with continuous, non-invasive measurement and 
monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and 
with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 
and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-
type facilities, and intra-hospital transport environments. 
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for 
prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and 
pulse rate of adult, pediatric, and neonatal patients during both no motion and motion conditions, and 
for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, 
hospital-type facilities, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is 
intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive 
reductions in airflow through the upper airway and into the lungs. 
6.8. Equipment 
The participating site will receive at minimum the following study specific equipment: 
- 
Two Capnostream monitors per site and accessories as described above in section 6.1 
- 
Two PM1000N-RR monitors and accessories as described above in section 6.4 
- 
Disposables for Capnostream and PM1000N-RR monitors, including etCO2 sampling lines and 
SpO2 sensors 
- 
Vital Sync™ related equipment as described above in section 6.2  
- 
As preferred by each site, a dedicated server may be provided to host the Vital Sync™ software  
- 
Microsoft Surface tablets may be provided to hospital nurses for remote monitoring   
 
Monitor’s calibration information is provided in their respective manual. Any additional maintenance or 
cleaning procedures should follow the operator’s institution guidelines. 
6.9. Product Use 
Disposition or use of product provided to the site by the study sponsor is for study patient use only. 
6.10. Product Training Requirements 
Product information will be included in the study training materials. A protocol for alarm management 
in Phase II, in agreement with hospital policy, will be developed and shared with nursing staff. 
6.11. Product Receipt and Tracking 
Medtronic will allow shipment of study devices prior to the Site Initiation Visit for training purposes only. 
Study devices should be used exclusively for patients enrolled in the study and can be used following 
official site activation from the Clinical Study Manager.  

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Participating sites will be provided with a sufficient number of Capnostream and Nellcor monitors. In 
addition, a sufficient number of etCO2 sample lines and SpO2 Sensors will be provided. 
Single use products (see Table 1) will be provided initially to participating sites in line with the number of 
expected patients to be enrolled. All the study devices will be provided free of charge by the sponsor for 
the duration of the study and they should be used only in this clinical study according to the CIP. They may 
be directly shipped to the sites or through the Medtronic field representative. 
The following records will be maintained by the site personnel at minimum for product delivery, receipt, 
use, disposal and return at each study center:  dates, quantities, lot/serial numbers, patient ID, and 
expiration dates, as applicable.  
6.12. Product Storage 
Product provided to the site should be stored in a secured area with access limited to delegated study 
staff. 
6.13. Product Return 
Product provided to the site shall be returned at the end of the study (excludes consumable products 
that have been used during the course of the study). When returning the clinical study equipment the 
proper use of skids and pallets, as well as boxes or crates of the appropriate size and materials for their 
contents, will minimize damage to the equipment. Containers should be properly cushioned and braced 
for shock and vibration mitigation and adequately sealed and filled when possible with the weight 
evenly distributed. 
Containers and inner pack material going out of the country should be used in conjunction with 
moisture-resistant material such as desiccant and barrier bags. Straps, seals and shrink wrapping help 
minimize pilferage of the equipment during transport. 
6.14. Product Accountability  
Reconciliation of product received, used, disposed and returned will be completed at the end of the 
study. Medtronic will perform periodic reconciliation of product to ensure traceability. 
7. Selection of Patients 
7.1 Study Population 
The target study population consists of post-surgical patients of adult age at high risk of developing 
respiratory and cardiovascular events on the hospital ward. 
7.2 Patient Enrollment 
A patient is considered enrolled in the study once he/she signs the Informed Consent form and meets 
the inclusion/exclusion criteria. 

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The investigator will maintain a log of all patients enrolled in the clinical investigation. A Patient 
Identification and Enrollment Log is a document to keep a confidential list of names of all patients 
participating in the clinical study. 
7.3 Inclusion Criteria 
 
Non-cardiac post-surgical patients at high risk of developing respiratory and cardiovascular 
events based on both ARISCAT3 and POSPOM4 scores.  
ARISCAT Score is an accurate risk score for predicting high or intermediate risk for postoperative 
pulmonary complications in patients undergoing surgery, calculated based on preoperative data 
such as on patient's age, preoperative SpO2, respiratory infection, anaemia, surgery type and 
duration3.  
POSPOM Score is an accurate risk score for predicting in-hospital mortality in patients 
undergoing surgery, calculated based on preoperative data such as on patient's age, planned 
surgery and presence of additional diseases or disorders4 . 
In particular, to be enrolled a patient must have: 
POSPOM score ≥ 24 (> 3 times the mortality average risk); 
OR 
ARISCAT score ≥ 26 (High or intermediate risk for postoperative pulmonary 
complications). 
 
Adult age (≥18 year old). 
 
Patient is able and willing to give informed consent. 
7.4 Exclusion Criteria 
1. Expected ward length of stay ≤24 hours. 
2. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or 
higher. 
3. Ventilated or intubated patients. 
4. Patient is unwilling or unable to comply fully with study procedures (including non-toleration of 
the capnography cannula or skin contact allergies to medical grade adhesives) due to any 
disease condition which can raise doubt about compliance and influencing the study outcome.  
5. Patient is a member of a vulnerable population, including legal incapacity or evidence that a 
patient cannot understand the purpose and risks of the study, regardless of authorized 
representative support. 
6. Patient is participating in another potentially confounding drug or device clinical study. 

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8. Study Procedures  
8.1 
 Schedule of Events 
Data will be collected for Screening, Enrollment Visit and Monitoring Period. Additional data will be 
collected for Adverse Events, Device Deficiencies and Protocol Deviations. 
Data collection requirements are summarized in Table 2. The study site personnel must report all study 
specific Adverse Events and changes in status of these Adverse Events from time of enrollment until a 
patient exits the study.  

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Table 2. Data Collection Requirements 
Data 
Screening 
Evaluation 
Enrollment 
Monitoring 
Study Exit 
Survey 
(at the study 
end) 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion Criteria Evaluation 
X 
 
 
 
 
Medical History 
 
X 
 
 
 
Demographic & Physical Examination 
 
X 
 
 
 
Vital Signs 
 
X 
X 
 
 
Supplemental Oxygen Use 
 
X 
X 
 
 
Surgery Information 
 
X 
 
 
 
Monitoring Duration 
 
 
X 
 
 
Medications 
 
X 
X 
 
 
Number/type of staff interventions (alarm 
and non-related)  
 
 
X 
 
 
Adverse Events 
 
X 
X 
X 
 
Device Memory Data 
 
 
X 
 
 
Patients’ compliance 
 
 
X 
 
 
Product Information 
 
 
X 
 
 
Device Deficiencies 
 
 
X 
X 
 
Protocol Deviations 
X 
X 
X 
X 
 
Reason for Study Exit  
 
 
 
X 
 
Date of Patient Discharge from Hospital  
 
 
 
X 
 
Clinical staff’s satisfaction and workflow 
impact
 
 
 
 
X 

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8.2 
 Patient Screening  
A consideration of all potential patients is recommended to minimize selection bias. All potential 
patients, whether finally enrolled in the study or not, will be entered on the Screening Log. 
If the patient is potentially eligible and willing to consider participation, written informed consent must 
be obtained. A review of patient’s files by the investigator is required to determine preliminary eligibility 
according to inclusion and exclusion criteria. Information included on the Screening Log includes: 
- 
Informed consent signature date, if applicable 
- 
Inclusion / exclusion criteria evaluation 
Patients will be considered a screen failure and immediately exited from the study if the patient signs 
the Informed Consent but fails to meet study inclusion/exclusion criteria prior to monitoring on the 
hospital ward. The reason for screen failure will be documented on the Screening Log. Premature exit 
from the study by a patient must be documented on the Study Exit eCRF. 
8.3 
 Prior and Concomitant Medications 
Medications relevant to the study (see Appendix C) will be listed in the eCRF. Details of relevant 
medications used during surgery and recovery will be collected at study enrollment and during the 
monitoring period. Medications will be administered to patients during the study according to hospital 
policy.  
8.4 
 Patient Consent 
The investigator or authorized designee must obtain written informed consent before any clinical study 
related activity takes place. Written informed consent must be obtained prior to surgery.  
In advance of the consent discussion, the patient should receive the EC approved Patient Information 
and Informed Consent Form. During the consent discussion, the investigator or his/her authorized 
designee must fully inform the patient of all aspects of the clinical study that are relevant to the 
patient’s decision to participate in the clinical study. If a patient is illiterate, an impartial witness must be 
present during the entire informed consent discussion. All items addressed in the Patient Information 
and the Informed Consent Form must be explained. The language used shall be as non-technical as 
possible and must be understandable to the patient and the impartial witness, where applicable.  
The patient must have ample time and opportunity to read and understand the Patient Information and 
the Informed Consent Form, to inquire about details of the clinical study, and to decide whether or not 
to participate in the clinical study. All questions about the clinical study should be answered to the 
satisfaction of the patient. 
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a patient to 
participate or to continue to participate in the clinical study. The informed consent process shall not 
waive or appear to waive the patient’s rights. 
When the patient decides to participate in the clinical study, the Informed Consent Form must be signed 
and personally dated by the patient and investigator or authorized designee. If applicable, the witness 
shall also sign and personally date the consent form to attest that the information in the Patient 
Information and Informed Consent Form was accurately explained and clearly understood by the 

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patient, and that informed consent was freely given. Detailed documentation of the process must be 
recorded in the patient’s case history. 
After all persons have signed and dated the Informed Consent Form, the investigator must provide the 
patient with a copy of the Patient Information and the Informed Consent Form. 
Medtronic will inform the investigators whenever information becomes available that may be relevant 
to the subject’s confirmed participation in the clinical study. The investigator or his/her authorized 
designee should inform the patient in a timely manner.  
Medtronic will revise the written Patient Information and Informed Consent Form whenever new 
information becomes available that may be relevant to the patient’s confirmed participation in the 
clinical study. The revised information will be sent for approval by the EC. After approval by the EC, a 
copy of this information must be provided to the any patients that are still participating in the study and 
re-consent obtained if requested by the EC.   
8.5 
 Enrollment 
The point of enrollment is completion of informed consent and confirmation of inclusion/exclusion criteria 
per the screening evaluation.  
Data collected for enrolled patients includes: 
 
Medical history (including surgical, apnea, and medical therapy such as oxygen use and opioid 
use) 
 
Demographic & Physical exam  
 
Vital signs 
 
Supplemental oxygen use 
 
Surgery information 
8.6 
 Treatment Assignment 
Patients will be randomly allocated 1:1 to either Capnostream™ 20p or Nellcor Monitoring Systems both 
in Phase I and in Phase II. The device allocation will be unblinded to both patient and physician. 
The sequence of treatments will be randomly permuted in blocks of 2 or 4 patients per block. The blocked 
randomization will be centralized and schedules will be created by the study statistician using statistical 
software. The randomization will be performed by the center via the EDC system (Oracle Clinical). To 
minimize the selection bias, the randomization procedure will be unpredictable. In this study a center 
stratified blocked randomization will be used, so that a separate permuted block randomization will be 
performed for each center. This guarantees treatment balance within strata.  
8.7 
 Monitoring Period 
Continuous monitoring from either Capnostream™ 20p or Nellcor Monitoring Systems will be performed 
on all patients for a minimum of 24 hours. The monitoring period will last up to patient’s full mobilization 
or up to a maximum of 72 hours, if the patient is still bed-ridden after two days post-surgery. 

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The monitoring period will start for patients once they arrive on the ward. For patients who are 
determined to be at high risk due to opioid therapy and not due to other pre-existing factors, monitoring 
of capnography and pulse oximeter data will start only after opioid therapy has been initiated. 
Monitoring may be discontinued if the patient is discharged from the hospital ward. 
During Phase I the alarm feature of the monitoring devices will be silenced and the screen information 
blinded. A regular check during the monitoring period should be completed to ensure the etCO2 filter line 
and SpO2 sensors are appropriately fitted on the patient. 
During Phase II the medical staff will be instructed to respond to alarm feature of the monitoring devices 
and their screen will be open. A guideline will be created to instruct the nurses in responding to alarms 
and changes in the monitored parameters. An alarm will be considered a false positive by the observer if 
the SpO2 sensor or the etCO2 filter line is off the patient or misplaced. Alarms will be considered true 
positive if the SpO2 sensor and etCO2 filter line placement is correct: observations on patient activity and 
subsequent interventions will be recorded in the eCRF to identify clinically significant or insignificant 
alarmed events.  As an example, patient activities such as talking, eating or gripping a book with the SpO2 
sensor compressed will be marked as true positive with details of the activity recorded to identify the 
alarmed event as potentially clinically insignificant if no medical intervention was taken. The Monitoring 
eCRF will be completed to document: 
 
Care pathway (location/transfer within hospital) 
 
Alarm threshold applied to the monitor (to be collected during the Monitoring Phase II only for 
each measured parameter, PR, RR, SpO2 and EtO2).  
 
Systolic blood pressure and level of consciousness using the AVPU scale to allow the 
retrospective NEWS analysis 
 
Monitoring duration 
 
Vital signs 
 
Supplemental oxygen use 
 
Medications 
 
Product information 
 
Alarm classification by the study nurses (clinically significant or insignificant) 
 
Action taken in reaction to device alarm feature 
 
Adverse Events (as described in Section 10.2) 
8.8 
Study Exit  
Once the monitoring period has ended the patient will be treated according to the hospital clinical 
practice. The patient will exit the study upon their discharge from the hospital. Any adverse events (as 
defined in section 10) observed between the end of the monitoring period and study exit are reportable 
(as described in section 10.2). The Study Exit eCRF will be used to document that the patient has exited 
from the study. The reason for study exit will be captured on the Study Exit eCRF. The date of study exit, 
which should correspond to the date of discharge from the hospital will also be captured here.  
If the study exit was for any reason other than normal study completion, refer to section 8.12 of the CIP, 
for appropriate Study Exit eCRF completion. 

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8.9 
 Assessment of Safety 
Methods and timing for assessing, recording, and analyzing safety parameters, including adverse events 
are described in the Adverse Event section. 
8.10 Recording Data 
The investigator will clearly mark the clinical records to indicate that the patient is enrolled in this 
clinical study. The patient’s medical records will be used as source documents. Worksheets may serve as 
source documentation in particular cases if a data field is not in the patient’s medical record. Details will 
be specified in the Monitoring Plan and specific guidance will be provided depending on the site 
practice. 
Capnostream™ 20p or Nellcor Monitoring Systems’ device memory data will be the source for the 
number and duration of RC markers. Device memory data will be exported to a flash memory device for 
each patient. The memory device will be stored at the investigation site. Device memory data will 
subsequently be downloaded and transferred to a secure server at Medtronic. 
The device data transfer process will be tested and verified during the site initiation process. This will be 
completed to ensure data quality and identify any process improvements to maximize quality, as 
needed. 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs which are derived from source documents, 
such as patient medical records, must be consistent with the source documents or the discrepancies 
need to be justified in a documented rationale, signed and dated by the (principal) investigator, to be 
filed in the patient file. All baseline and medical history data must be derived from source documents.  
Only authorized persons can complete eCRFs. Training will be provided to site personnel on the use of 
data collection tools. CRFs shall be electronically signed by investigators (physician) or by authorized site 
staff as specified on the Delegated Tasks List. The final version of eCRFs will be provided to the 
investigation sites when the investigational site has been declared ready for the study. 
It is expected that eCRF will be completed within 15 days from the performed visit or as soon as source 
documents are available, except for Serious Adverse Events that require immediate reporting (see Table 
3) and for Protocol Deviation requiring pre-approval. A delayed completion of the eCRF will not be 
considered a Protocol Deviation.  
Sponsor study personnel will review all collected data and create data queries for missing data that 
impacts data analysis. Queries will be sent to the investigator or appropriate support staff for resolution. 
Data reported on the eCRFs that are derived from source documents must be consistent with the source 
documents. Where copies of the original source document as well as print outs of original electronic 
source documents are retained, these shall be signed and dated by a member of the investigational site 
team with a statement that it is a true reproduction of the original source document.  

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8.11 Deviation Handling 
Deviations are instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
CIP. Intentional deviations are not permitted, except where necessary to protect the life or physical well-
being of a patient in an emergency situation. All deviations must be documented and explained, 
regardless of the reason for the deviation. Deviations will be documented on the Protocol Deviation 
eCRF. 
If circumstances permit, the principal investigator is required to obtain prior approval from Medtronic 
before initiating actions that are considered study deviations. Prior approval from EC or competent 
authority might also be needed if related to safety, well-being or integrity of scientific data. Prior 
approval is not always realistic in situations where unforeseen circumstances are beyond the 
investigator’s control. However, also in these cases, the event is considered a deviation and shall be 
reported. 
In any emergency situation the investigator shall exercise his/her judgment to safeguard the patient’s 
interest. Such deviations from the CIP do not require the prior approval of Medtronic. The investigator 
shall report the deviation as soon as possible to Medtronic and the reviewing EC, if applicable. 
Medtronic will inform the regulatory authorities, if required. 
Repetitive or serious investigator compliance issues may result in the need to initiate a corrective action 
plan, and in some cases freeze enrollment or ultimately terminate the investigator’s participation in the 
clinical study. Examples of serious investigator compliance issues that could determine site 
disqualification when repeated are: 
- 
Failure to obtain and/or document informed consent; 
- 
Inadequate device accountability; 
- 
Failure to notify sponsor and or EC of reportable unanticipated adverse device effects, adverse 
events, device deficiencies, and/or adverse drug reactions within required timelines. 
 
Medtronic is responsible for reviewing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, additional training, terminate the 
study, etc.). 
8.12 Patient Withdrawal or Discontinuation  
If a patient is withdrawn from the clinical study, the reason for withdrawal shall be recorded on the 
Study Exit eCRF and in the patient’s medical record. 
Possible reasons for withdrawal from the study are: 
 
Adverse Event; 
 
Patient withdrew consent; 
 
Investigator withdrew patient from the study for medical reasons; 
 
Investigator withdrew patient from the study due to inclusion/exclusion criteria not met. 
No patient follow-up is scheduled as per study design (excluding resolution of ongoing adverse events). 
Patients withdrawn for reasons other than screen failure will not be replaced. 

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Withdrawn patients will be treated according to standard clinical practice. 
9. Risks and Benefits 
9.1 
Potential Risks 
Devices used in this clinical study are commercially available and Medtronic is not aware of any concerns 
with these products. In the clinical study, the products will be used in accordance with their labeling, 
therefore no risks other than the risks typically associated with routine device use are anticipated.  
Risks will be minimized by careful assessment by the patient’s doctor prior to, during, and after the 
monitoring phase. In addition, apart from the monitoring, patients are treated according to general 
clinical practice, so no extra tests or follow-ups are required for the study. Therefore, no additional risks 
are associated with participation in this clinical study. 
Possible risks associated with Capnostream™ 20p or Nellcor monitoring is mild to moderate skin 
irritation or discomfort (redness, itching, rash, pressure) associated with the pulse oximetry sensor or 
related to the application or removal of the sensor. The skin will be assessed before and after the 
application of the pulse oximetry sensors.   Patients with known skin contact allergies to medical grade 
adhesives will not be recruited. 
Possible risks associated only with Capnostream™ 20p is mild to moderate skin irritation or discomfort 
involved in wearing a filterline similar to a supplemental O2 tube with an added oral scoop to collect a 
gas sample near the mouth for CO2 analysis.   The design mitigation to reduce skin allergic reactions is 
the use of latex free, ISO 10993 compliant components.  Design of the oral/nasal interface and low 
pump suction pressure for sampling are means to reduce risk of discomfort. 
9.2 
Potential Benefits 
Patients’ participation in this study may offer no additional benefit in respect to the same treatments 
provided outside of the study. 
Possible benefits for participating in this study include the following (although others are possible): 
- 
Study patients may benefit from the structured, well-controlled clinical surveillance provided 
during the monitoring phase. 
- 
The information gained from this study could result in the improved post-surgical management 
of other patients.  Additionally, information collected from this study may assist in the design of 
a subsequent outcome study, the design of new product(s)/therap(y/ies) and/or instructions for 
use. 
9.3 
Risk-Benefit Rationale 
Medtronic believes that the potential risks associated with the conduct of this study are minimal, using 
non-significant risk, non-invasive study devices for the following reasons: 
- 
All the devices used in the study are commercially available and used within their intended use. 
- 
Additional surveillance will be provided for close monitoring and recording of the patients’ 
clinical status. 

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10.  Adverse Events and Device Deficiencies 
In this study the following AEs will be collected: 
 
All AEs with an underlying respiratory cause  
 
All SAEs  
 
All adverse device effects (ADE) 
 
In addition, device deficiencies (DD) will be collected for this study.  
RC markers will not be considered AE if the patient is asymptomatic and no actions are taken. 
10.1 Definitions/Classifications 
Definitions according to ISO 14155:2011 will be used in this study. 
Where the definition indicates “device”, it refers to any product used in the study. See product 
description section 6 for product information. 
Table 3. Definition of Adverse Events and Device Deficiency 
Term 
Abbreviation 
ISO Definition 
Adverse Event 
AE 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices. 
Adverse Device Effect 
ADE 
Adverse event related to the use of an investigational medical 
device. 
NOTE 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error 
or from intentional misuse of the investigational medical device. 
Serious Adverse Device 
Effect 
SADE 
Adverse device effect that has resulted in any of the consequences 
characteristic of a Serious Adverse Event.   

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Term 
Abbreviation 
ISO Definition 
Serious Adverse Event 
SAE 
An adverse event that  
1. led to death, 
2. led to serious deterioration in the health of the subject, 
that either resulted in  
3. resulted in a life-threatening illness or injury, or 
4. resulted in a permanent impairment of a body structure 
or a body function, or 
5. resulted in-patient or prolonged hospitalization, or  
6. led to a medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to 
a body structure or a body function, 
7. led to fetal distress, fetal death or a congenital 
abnormality or birth defect.   
NOTE:  Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in 
health, is not considered a serious adverse event. 
Unanticipated Serious 
Adverse Device Effect 
USADE 
Serious adverse device effect which by its nature, incidence, severity 
or outcome has not been identified in the current version of the risk 
analysis report. 
NOTE:  Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been 
identified in the risk analysis report. 
Device Deficiency 
DD 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors, and 
inadequate labelling. 
10.2 Reporting of Adverse Events 
AE information will be collected throughout the study and reported to Medtronic on an AE eCRF, one for 
each adverse event. It is the responsibility of the investigator to identify the occurrence of adverse 
events to ensure that the information is accurately documented in the medical record and on the eCRFs. 
Device Deficiency (DD) information will also be collected throughout the study and reported to 
Medtronic on a Device Deficiency eCRF. DDs require immediate reporting if they did not lead to an 
adverse event but could have led to a serious adverse device effect (SADE): 
 
if either suitable action had not been taken, 
 
if intervention had not been made, or 
 
if circumstances had been less fortunate 
AE documentation will include the following information at a minimum: 
 
Date of event 

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 
Time of the event 
 
Diagnosis and description (including confirmation of respiratory nature) 
 
Actions taken / treatment (including vital signs, and date and time of rescue related actions 
when applicable) 
 
Assessment of seriousness 
 
Relatedness to the event (including opioid therapy or device) 
 
Outcome or resolution and date of the resolution 
 
For AEs that require immediate reporting, initial reporting may be done by phone, fax, e-mail, or 
preferably on the eCRF completing as much information as is available. The completed AE eCRF must be 
sent to Medtronic as soon as possible. 
In case the investigator requires information from the sponsor in an emergency situation, the 
investigator can contact Technical Services or the Medtronic Study Manager. Contact information will be 
provided under separate cover. 
The sponsor will ensure timely Adverse Event reporting to meet local regulatory requirements. 
A list of anticipated adverse events that are expected in nature is included in Appendix A of this CIP. 
 
Table 4. Reporting Requirements for Events 
Serious Adverse Device Effects (SADE), including Unanticipated Serious Adverse Device 
Effect (USADE): 
Investigator submit to: 
 
Medtronic 
Immediately after the investigator first learns of the event or of 
new information in relation with an already reported event.  
Regulatory Authority 
As per local reporting requirement.  
EC 
Submit to EC per local reporting requirement. 
Sponsor submit to: 
 
Regulatory Authorities  
Reporting timeframe as per local requirement. 
EC 
Submit to EC per local reporting requirement. 
Serious Adverse Events (SAE) 
Investigator submit to: 
 
Medtronic 
Immediately after the investigator first learns of the event or of 
new information in relation with an already reported event.  

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Regulatory Authority 
As per local reporting requirement.  
EC 
Submit to EC per local reporting requirement. 
Sponsor submit to: 
 
Regulatory Authorities  
Reporting timeframe as per local requirement. 
EC 
Submit to EC per local reporting requirement. 
Adverse Device Effects (ADE) 
Investigator submit to: 
 
Medtronic 
Immediately after the investigator first learns of the event.  
Regulatory Authority 
As per local reporting requirement.  
EC 
Submit to EC per local reporting requirement. 
Sponsor submit to: 
 
Regulatory Authorities 
Reporting timeframe as per local requirement 
EC 
Submit to EC per local reporting requirement. 
All other AEs 
Investigator submit to: 
 
Medtronic 
Submit in a timely manner after the investigator first learns of the 
event. 
Regulatory Authority 
As per local reporting requirement.  
EC 
Submit to EC per local reporting requirement. 
Device Deficiency with SADE potential 
Investigator submit to: 
 
Medtronic 
Immediately after the investigator first learns of the deficiency or of 
new information in relation with an already reported deficiency.  
Regulatory Authorities 
As per local reporting requirement. 
EC 
As per local reporting requirement. 
Sponsor submit to: 
 

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Regulatory Authorities 
As per local reporting requirement. 
EC 
As per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to 
 
Medtronic 
Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory Authorities 
As per local reporting requirement. 
EC 
As per local reporting requirement. 
10.3 Patient deaths 
All patient deaths and adverse events that lead to death must be reported by the investigator to 
Medtronic. Initial reporting may be done by phone, fax, e-mail, or preferably on the eCRF completing as 
much information as is available. The completed AE eCRF must be sent to Medtronic as soon as possible 
after the investigator first learns of the death. 
10.4 Complaint reporting 
A Product Complaint is any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that 
has been placed on the market. 
Market-released devices require product complaint reporting. The reporting of product complaints is 
not part of the clinical study and should be done via regular channels for product complaint reporting in 
addition to the AE reporting requirements.  Refer to local regulations for reporting requirements.  
11. Clinical Event Committee 
This study will not have a Clinical Event Committee (CEC).  
Since only two German sites will be involved, assessment of study specific endpoints and/or events will 
be performed by delegated site sub-Investigators that will perform cross-site events assessment 
12. Statistical Design and Methods 
12.1 Sample size justification 
The sample size calculation is based on primary endpoint and it was estimated using data from previous 
studies with a precision-based calculation. Recent data on post-surgical patient have shown a proportion 
of patient with the RC markers for the SpO2 ≤ 85% for ≥ 3 minutes at 13%17 and for RR ≤ 8 or ≥ 22 bpm 

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for ≥ 3 minutes at 1.4%36 in patients undergoing opioid therapy. Using this information, a minimum 
proportion of 10% of patients with RC markers with a sample size of 260 patients will be able to obtain a 
95% confidence level with a precision of 5% (ranging from 5% to 10%) and a power of at least 0.80 
defined as the probability of achieving the desired precision. Considering a 10% withdrawal or potential 
dropouts and a potential attrition rate to monitoring compliance of 5% a total of approximately 210 
patients will be enrolled. This cohort will be used prospectively for the blinded and not blinded phase 
with a ratio 1:2 respectively to minimize not blinded monitored patients. The blinded phase will enroll 
70 patients randomly allocated 1:1 in the Capnostream 20p and PM1000N-RR arm while the not blinded 
phase will enroll 140 patients with same randomized schedule.   
 
12.2 Data analysis and reporting 
The data will be collected from each center in the eCRF data base via Oracle Clinical. A specific account 
number will be given to each center to access the system from any internet-enabled computer. Access 
to Internet is required for the sites to enter data into the system. User Identification codes will be 
created to identify data input from each center. The clinical data will be entered by the study staff and 
transmitted to the central database in an anonymous format so that the study sponsor will not be able 
to identify the patient, in accordance with the European Data Privacy Directive. Electronic automatic and 
manual queries will be generated for missing, incorrect or doubtful data and sent directly to the study 
center via Oracle Clinical. All the detailed data analyses are described in the Statistical Analysis Plan. Any 
deviations from this section and/or the Statistical Analysis Plan will be described and justified in the Final 
Clinical Study Report, as appropriate. 
 
12.3 Analysis of clinical data 
Patient demographics and baseline characteristics will be presented using appropriate summary 
statistics. This includes mean and standard deviation, minimum, maximum and median with the 
interquartile range [IQR] for continuous variables and counts and percentages for categorical variables. 
Summary statistics will be reported with maximum 2 decimals, as appropriate. The SAS software (SAS 
Institute Inc., Cary, NC, USA) will be used to perform statistical analyses. Statistical tests will be based on 
a two-sided significance level of 0.05. Graphical representations will be used as deemed appropriate. No 
adjustments for multiple comparisons or multiple look at data will be performed. Outliers and influential 
observations will be identified via graphical plots and according to study team decision the analysis 
could be repeated excluding potential outliers. In case of missing data, no imputation method will be 
implemented for analysis.  
The Full Analysis Set (FAS) will be used for primary final analysis. Any patient who does not satisfying the 
inclusion/exclusion criteria will be eliminate from the FAS population. Details of endpoints analyses and 
additional analysis will be described in the Statistical Analysis Plan. The analyses of primary objective on 
the proportion of patient with at least one RC markers will be reported together with their 95% 
confidence intervals and separately for each arm and phase of the study (see primary endpoint 
definition). When comparison of clinical primary outcomes is conducted the propensity score methods 
could be used to control for biases and confounding which may be due to the nature of this study. The 

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difference between the two groups within phase and between phases within groups will be analyzed by 
means of unpaired t-test or Mann-Whitney test according to the normal or non-normal distribution. For 
one secondary outcome the logistic regression model will be used to check potential predictors. 
Bivariate odds ratios (ORs) and 95% confidence intervals (95% CIs) will be estimated for each predictor. 
A multivariate logistic regression model will be performed according to univariate model’s results. Other 
secondary outcomes will be performed using sensitivity and specificity analysis. 
 
13. Ethics 
13.1  Statement(s) of Compliance  
This clinical study will be conducted in compliance with the Declaration of Helsinki (2013), ISO 14155: 
2011 and local laws and regulations, including data protection laws, the Clinical Trial Agreement, GCP 
and the CIP. All principles of the Declaration of Helsinki have been implemented in this clinical study by 
means of the informed consent process, EC approval, clinical study training, clinical trial registration, 
risk-benefit assessment and publication policy. Adverse Event and Device Deficiency handling in the 
LIFEGUARD will be ISO 14155:2011 compliant, with the following exception: only those adverse events 
which are deemed to have an underlying respiratory cause, all Serious AEs, ADEs and DDs will be 
collected. Medtronic will prepare all the required regulatory authority documents and send them to the 
respective authority, if applicable. 
The clinical study will not begin until EC and regulatory authority approvals, as appropriate, are received.   
13.2  Ethics Committee  
Prior to enrolling patients in this clinical study, each investigation site’s EC will be required to approve 
the current Clinical Investigation Plan, the Patient Information and Informed Consent form, including 
any other written information to be provided to the patients and, if applicable, materials used to recruit 
patients. EC approval of the clinical study must be received in the form of a letter and provided to 
Medtronic before commencement of the clinical study at an investigation site. The approval letter must 
contain enough information to identify the version or date of the documents approved. If this 
information is not contained in the approval letter, it must be retrievable from the corresponding 
submission letter. In addition, the approval letter needs to be accompanied by an EC roster or letter of 
compliance, to allow verification that the investigator, other investigation site personnel, and/or 
Medtronic personnel are not members of the EC. If they are members of the EC, written documentation 
is required stating that he/she did not participate in the approval process. If the EC imposes any 
additional requirements (e.g. safety reports, progress reports etc.), Medtronic will prepare the required 
documents and send them to the EC.  
EC must inform Medtronic of any change in status of its approval once the investigational site has 
started enrollment. If any action is taken by an EC with respect to the investigation, that information will 
be sent directly to Medtronic who will immediately inform the investigator. 

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13.3  Regulatory Requirements / Competent Authorities 
The study shall be conducted in accordance with the laws and regulations of the countries in which the 
clinical study is conducted, including data protection laws. In countries where submission to the 
regulatory authority is required per local law, no patients will be enrolled in the clinical study until the 
particular regulatory authority has approved the current Clinical Investigation Plan of the clinical study 
and other documents as required according to the local requirements. If the regulatory authority 
imposes any additional requirements (e.g. safety reports, progress reports etc.), Medtronic will prepare 
the required documents and send them to the respective authority. 
13.4  Patient Compensation and Indemnification 
While a fee will be provided to the participating centers for each enrolled patient, no additional 
fee/reimbursement will be provided to the patients.  
This trial is conducted in Germany, therefore reimbursement and indemnification will be addressed on a 
country specific basis in the study documents and site Clinical Trial Agreements. 
Patients are treated according to general clinical practice, so no extra tests or follow-ups are required 
and therefore no risks other than the risks typically associated with a routine device use are anticipated. 
If injuries happen, it will be treated in the same manner as per routine clinical practice. Costs of these 
treatments will be covered by the national health insurance (as applicable per country) as in usual 
clinical practice. The patient pays his/her co-payment for that treatment. No special compensation will 
be paid by the Sponsor. 
 
14. Study Administration 
14.1 Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of the study per regulations. 
Appropriately trained Medtronic personnel or delegates appointed by Medtronic will perform study 
monitoring at the study center in order to ensure that the study is conducted in accordance with the 
Clinical Investigation Plan (CIP), the Clinical Trial Agreement, and applicable regulatory requirements. 
Medtronic must therefore be allowed access to the patient’s clinic and hospital records when so 
requested as per the Patient Consent Form and Clinical Trial Agreement. 
Frequency of monitoring visits will occur based on patient enrollment, duration of the study, study 
compliance, findings from previous monitoring visits and any suspected inconsistency in data that 
requires investigation. Regulatory documents (e.g., Informed Consent Form, EC approval letters and 
Clinical Trial Agreements, etc.) will be reviewed at each study center. 
A Study Initiation Visit will be conducted after the EC approval and study agreement signature to train 
the investigational site. Interim Monitoring visits will be conducted to assess site study progress, the 
investigator’s adherence to the CIP, regulatory compliance including but not limited to EC approval and 
review of the study, maintenance of records and reports, and review of source documents against 
patient eCRFs. Monitors facilitate site regulatory and study compliance by identifying findings of non-

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compliance and communicating those findings along with recommendations for preventative/ corrective 
actions to site personnel. This may be done in collaboration with the study management and the local 
field personnel, if available. Communication with the site personnel occurs during the visit and following 
the visit via a written follow-up letter. Monitors may work with study personnel to determine 
appropriate corrective action recommendations and to identify trends within the study or at a particular 
center. Study closure visits will be conducted via telephone or on site at each enrolling study center. 
The Principal Investigator should be available during the Monitoring Visits or at least should be available 
to discuss by phone any eventual finding resulting from the Monitoring Visit. 
14.2 Data Management 
14.2.1 Patient Data 
Patient data will be collected using the Remote Data Capture (RDC) management system. RDC is an 
interface that allows site users at sites to enter data directly into the study database via a web interface. 
RDC is an example of an Electronic Data Capture method (EDC). 
RDC, developed by Oracle Clinical, utilizes electronic Case Report Forms (eCRFs). The application and 
data will be maintained on Medtronic servers. The system is a 21 CFR Part 11 compliant system which 
maintains an audit trail and change management system, including the original entry for comparison 
purposes.  
Data will be reviewed using programmed and manual data checks.  Data queries will be made available to 
centres for resolution.  Study management reports may be generated to monitor data quality and study 
progress.   At the end of the study, the data will be archived for the appropriate retention period. 
Following this period, Medtronic will only retain anonymized data and will delete any personal data. 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing. 
CRFs must be maintained and signed electronically within the electronic data capture system during the 
study. 
14.2.2 Device Data 
Device memory data will be exported to a flash memory device for each patient. The memory device will 
be stored at the investigation site. Device memory data will subsequently be downloaded and 
transferred to a secure server at Medtronic. 
 
14.3 Direct Access to Source Data/Documents  
14.3.1 Accessibility of Investigation Site Staff and Study Materials 
The principal investigator(s), his/her delegate(s) and the study coordinator(s) shall be accessible to 
Medtronic Clinical Monitors and the Clinical Study Manager. This accessibility is of particular importance 
for reviewing data on the electronic Case Report Form (eCRF). Direct access to patient medical files for 

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source data verification (if applicable) will need to be granted and prepared prior to any monitoring 
visits. 
14.3.2 Audits and Investigation Site Inspections 
In addition to regular monitoring visits, Medtronic may conduct audits at participating investigation 
sites. The purpose of an audit is to verify the adequate performance of the clinical study related 
activities by personnel dependent of the employees involved in the clinical study. Regulatory authorities 
may also perform inspections at participating investigation sites. Any regulatory authority inspection 
announcements shall be forwarded immediately to Clinical Study Manager. 
The investigator and/or institution shall permit Medtronic and regulatory bodies direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study-
related monitoring, audits, EC review (if applicable), and regulatory inspections. 
14.4 Confidentiality 
All records and other information about patients participating in this study will be treated as 
confidential. The identity of a patient will never be disclosed in the event that study data are published.  
Patient confidentiality will be maintained throughout the clinical study in a way that ensures the 
information can always be tracked back to the source data. For this purpose, a unique patient 
identification code will be assigned and used to allow identification of all data reported for each patient. 
Study data may be made available to third parties, e.g. in the case of an audit performed by regulatory 
authorities, provided the data are treated confidentially and that the patient’s privacy is guaranteed. 
Sites will maintain patient privacy according to local and national regulations and institutional 
requirements.  
The confidentiality of data must be observed by all parties involved at all times throughout the study.  
14.5 Liability 
Covidien AG (represented in the European Union by Covidien Services Europe) is an indirect wholly 
owned subsidiary of Medtronic plc, which as the parent company of such entity maintains appropriate 
clinical study liability insurance coverage as required under applicable laws and regulations and will 
comply with applicable law and custom concerning specific insurance coverage. If required, a Clinical 
Trial Insurance statement/certificate will be provided to the EC. 
14.6 CIP Amendments 
Amendments to this Clinical Investigation Plan shall be agreed upon between Medtronic and 
investigator(s) and be recorded with a justification for the amendments.  
The investigator may propose any appropriate modification(s) of the Clinical Investigation Plan or 
investigational device or investigational device use. Medtronic will review this proposal and decide 
whether the modification(s) will be implemented. 
Medtronic will submit any significant amendment to the Clinical Investigation Plan, including a 
justification for this amendment, to the appropriate regulatory authorities and to the EC, if applicable. 

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Administrative amendments to the Clinical Investigation Plan will be submitted to the EC and 
appropriate regulatory authorities for notification, if applicable. 
14.7 Record Retention 
14.7.1 Investigator Records 
At a minimum, the following records must be kept by the investigator: 
 
Clinical Investigation Plan and, if applicable, any amendments 
 
Medtronic and EC approved Informed Consent 
 
Regulatory Authority approval or notification, if applicable 
 
Fully signed clinical trial agreement and confidentiality agreement (if not included in the 
clinical trial agreement) 
 
Financial disclosures 
 
Insurance certificates, if applicable 
 
Completed Delegated Task List and Curriculum Vitae of Primary Investigator  
 
Training documentation of all investigation site personnel 
 
Relevant communications 
 
Patient Identification and Enrollment Log Form 
 
Signed, dated and fully executed informed consent forms 
 
Fully executed eCRFs and corrections 
 
Copy of the Study Final Report 
 
The investigator must retain the Investigator Site File, patient medical files and eCRF data in accordance 
with local law and regulations for a minimum period of 10 years after study completion. 
The investigator should take measures to prevent accidental or early destruction of the clinical study 
related materials. 
14.7.2 Sponsor Records 
At a minimum, the sponsor will keep the following records: 
 
All essential study documents and correspondence that pertains to the clinical study 
 
CIP and, if applicable, any amendments 
 
Curriculum vitae of Primary investigators, Delegated Task Lists and training records of 
investigators and site staff 
 
EC approvals/notifications and regulatory approvals/notifications 
 
Signed Clinical Trial Agreements and signed agreements with third parties 
 
Insurance certificates, if applicable 
 
Medtronic and EC approved Informed Consents 

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 
Site selection reports, site initiation reports and monitoring visit reports  
 
Adverse event reports 
 
Financial disclosures 
 
Fully executed eCRF data and corrections 
 
Device Memory data 
 
Study Final Report 
14.8 Publication and Use of Information 
The results of this clinical study will be submitted for publication. Publications and presentations 
referring to LIFEGUARD study will be coordinated by Medtronic to allow the use of all available data. 
The study will be recorded on www.clinicaltrials.gov before the first enrollment. 
The following publication policy will have to be adhered to by all participating investigation sites. 
Authorship on any publication(s) resulting from this clinical study will be assigned according to 
substantial contributions to conception and design, acquisition of data, or analysis and interpretation of 
data, drafting the article or revising it critically for important intellectual content and final approval of 
the version to be published. This is in accordance with the Vancouver principles (The Uniform 
Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical 
Publication, ICMJE, October 2008), as agreed upon by the editors of all major medical journals.  
The number of authors will be dependent on the regulations of the concerning journal. Names of all 
participating investigators will appear in the Acknowledgment of the paper. 
Medtronic as the owner of the data can use the data and/or any results derived from the data or 
publications based on that data for any lawful purposes, including marketing purposes, further research 
and development of devices or educational use, in compliance with applicable data privacy regulations. 
The study sponsor will collect only pseudonymized data, and monitor study records. 
Participating patients will not be identified in any published reports about the clinical study. 
14.9 Suspension or Early Termination 
Medtronic or Regulatory Authority may decide to suspend or prematurely terminate the clinical study.  
If the clinical study is terminated prematurely or suspended, Medtronic shall promptly inform the 
clinical investigators of the termination or suspension and the reason(s) for this. The investigator shall 
then promptly inform the reviewing EC and the study patients or their legal representative. 
Medtronic, EC or Regulatory Authority may decide to suspend or prematurely terminate an investigation 
site (e.g. in case of non-compliance to the CIP or lack of enrollment). If an investigation site is suspended 
or prematurely terminated, Medtronic shall promptly inform the investigator(s) of the termination or 
suspension and the reason(s) for this. Medtronic shall then promptly inform the reviewing EC, if 
required, the study patients or their legal representative. 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify or immediately stop the 

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clinical study in the respective investigation site and immediately inform the sponsor and EC, if 
applicable. 
In case of early investigation site suspension or termination patients will be followed-up as per standard 
of care. 
In case of close out, the investigators will be notified and notification/report to EC and Regulatory 
Authority will be done, if required. 
 
 

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15. References 
1.  
Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous 
oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-
controlled analgesia. Anesth Analg [Internet] 2007 [cited 2015 Jun 12];105(2):412–8. Available 
from: http://www.ncbi.nlm.nih.gov/pubmed/17646499 
2.  
Weissbrod MRR, Ajizian FJOS. Smart respiratory monitoring : clinical development and validation 
of the IPI TM ( Integrated Pulmonary Index ) algorithm. J Clin Monit Comput 2016; 
3.  
Mazo V, Sabate S, Canet J, et al. Prospective external validation of a predictive score for 
postoperative pulmonary complications. Anesthesiology [Internet] 2014;121(2):219–31. Available 
from: 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=24901240 
4.  
Le Manach Y, Collins G, Rodseth R, et al. Preoperative Score to Predict Postoperative Mortality 
(POSPOM): Derivation and Validation. Anesthesiology 2016;124(March):570–9.  
5.  
Sabate S. Predicting postoperative pulmonary complications. Curr Opin Anaesthesiol 
2014;27:201–9.  
6.  
Fernandez-Bustamante A, Frendl G, Sprung J, et al. Postoperative Pulmonary Complications, Early 
Mortality, and Hospital Stay Following Noncardiothoracic Surgery. JAMA Surg [Internet] 
2016;39(9):2163–72. Available from: 
http://archsurg.jamanetwork.com/article.aspx?doi=10.1001/jamasurg.2016.4065 
7.  
Kahan BC, Koulenti D, Arvaniti K, et al. Critical care admission following elective surgery was not 
associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care 
Med [Internet] 2017;1–9. Available from: http://link.springer.com/10.1007/s00134-016-4633-8 
8.  
Moreno RP, Pearse R, Rhodes A. American Society of Anesthesiologists Score: Still useful after 60 
years? Results of the EuSOS Study. Rev Bras Ter Intensiva 2015;27(2):105–12.  
9.  
Canet J, Sabaté S, Mazo V, et al. Development and validation of a score to predict postoperative 
respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J 
Anaesthesiol [Internet] 2015 [cited 2015 Jun 11];458–70. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/26020123 
10.  
Weingarten TN, Herasevich V, McGlinch MC, et al. Predictors of Delayed Postoperative 
Respiratory Depression Assessed from Naloxone Administration. Anesth Analg [Internet] 2015 
[cited 2015 Jul 9];XXX(Xxx):1–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25993390 
11.  
Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based 
postsurgical pain control using administrative claims data from a large health system: opioid-
related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy 

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[Internet] 2013;33(4):383–91. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23553809 
12.  
Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on 
outcomes in selected surgical patients. J Pain Palliat Care Pharmacother [Internet] 2013 [cited 
2015 Jun 11];27(1):62–70. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23302094 
13.  
Oderda G, Pharm D. Challenges in the Management of Acute Postsurgical Pain. 2012; 
14.  
Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a 
population-based surgical cohort. Anesthesiology [Internet] 2010;113(6):1338–50. Available 
from: http://www.ncbi.nlm.nih.gov/pubmed/21045639 
15.  
Le Manach Y, Collins G, Rodseth R, et al. Preoperative Score to Predict Postoperative Mortality 
(POSPOM). Anesthesiology 2016;124:570–9.  
16.  
Reynolds PQ, Sanders NW, Schildcrout JS, Mercaldo ND, St Jacques PJ. Expansion of the surgical 
Apgar score across all surgical subspecialties as a means to predict postoperative mortality. 
Anesthesiology 2011;114(6):1305–12.  
17.  
Sun Z, Sessler DI, Dalton JE, et al. Postoperative Hypoxemia Is Common and Persistent: A 
Prospective Blinded Observational Study. Anesth Analg [Internet] 2015 [cited 2015 Sep 
25];121(3):709–15. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26287299 
18.  
Hodgetts TJ, Kenward G, Vlackonikolis I, et al. Incidence , location and reasons for a v oidable in-
hospital cardiac arrest in a district general hospital. 2002;54.  
19.  
Smith AF, Wood J. Can some in-hospital cardio-respiratory arrests be prevented ? A prospective 
survey. 1998;37:133–7.  
20.  
Buist MD, Moore GE, Bernard SA, Waxman BP, Anderson JN. arrests in hospital : preliminary 
study. 2002;324(February):5–9.  
21.  
Bellomo R, Goldsmith D, Uchino S, et al. Prospective controlled trial of effect of medical 
emergency team on postoperative morbidity and mortality rates*. 2004;32(4):0–5.  
22.  
Churpek MM, Yuen TC, Edelson DP. Risk stratification of hospitalized patients on the wards. 
Chest [Internet] 2013 [cited 2015 Oct 1];143(6):1758–65. Available from: 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3673668&tool=pmcentrez&rendert
ype=abstract 
23.  
Hogan J. Why don’t nurses monitor the respiratory rates of patients? Br J Nurs 2006;15(9):489–
93.  
24.  
Smith M, Chiovaro J, O’Neil M, et al. Early Warning System Scores: A Systematic Review. VA 
Evidence-based Synth Progr Reports 2014; 

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25.  
Yu S, Leung S, Heo M, et al. Comparison of risk prediction scoring systems for ward patients: a 
retrospective nested case-control study. Crit Care [Internet] 2014 [cited 2015 Oct 13];18(3):R132. 
Available from: http://ccforum.com/content/18/3/R132 
26.  
Respiratory Compromise - Respiratory Compromise Institute [Internet]. [cited 2016 Jan 
21];Available from: http://www.respiratorycompromise.org/ 
27.  
Quach JL, Hons B, Downey AW, et al. Characteristics and outcomes of patients receiving a 
medical emergency team review for respiratory distress or hypotension ☆. J Crit Care 
2008;23:325–31.  
28.  
Maddox RR, Oglesby H, Williams CK, Fields M, Danello S. Continuous Respiratory Monitoring and 
a “ Smart ” Infusion System Improve Safety of Patient-Controlled Analgesia in the Postoperative 
Period. :1–13.  
29.  
Burgess LP a., Herdman TH, Berg BW, Feaster WW, Hebsur S. Alarm limit settings for early 
warning systems to identify at-risk patients. J Adv Nurs [Internet] 2009 [cited 2015 Oct 
1];65(9):1844–52. Available from: http://doi.wiley.com/10.1111/j.1365-2648.2009.05048.x 
30.  
Maddox RR, Williams CK, Oglesby H, Butler B, Colclasure B. Clinical experience with patient-
controlled analgesia using continuous respiratory monitoring and a smart infusion system. Am J 
Health Syst Pharm [Internet] 2006 [cited 2015 Jun 11];63(2):157–64. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/16390930 
31.  
Deitch K, Chudnofsky CR, Dominici P, Latta D, Salamanca Y. The utility of high-flow oxygen during 
emergency department procedural sedation and analgesia with propofol: A randomized, 
controlled trial. Ann Emerg Med 2011;58(4):360–4.  
32.  
Burton JH, Harrah JD, Germann C a, Dillon DC. Does end-tidal carbon dioxide monitoring detect 
respiratory events prior to current sedation monitoring practices? Acad Emerg Med [Internet] 
2006 [cited 2015 May 25];13(5):500–4. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/16569750 
33.  
Cacho G, Barbado A, Ojea R. Capnography is superior to pulse oximetry for the detection of 
respiratory depression during colonoscopy. 2010;102(4):86–9.  
34.  
Hunter CL, Silvestri S, Dean M, Falk JL, Papa L. End-tidal carbon dioxide is associated with 
mortality and lactate in patients with suspected sepsis. Am J Emerg Med [Internet] 
2013;31(1):64–71. Available from: http://dx.doi.org/10.1016/j.ajem.2012.05.034 
35.  
Touma O, Davies M. The prognostic value of end tidal carbon dioxide during cardiac arrest: A 
systematic review. Resuscitation 2013;84(11):1470–9.  
36.  
Mccarter T, Shaik Z, Scarfo K, Thompson LJ, Rt R. Capnography Monitoring Enhances Safety of 
Postoperative Patient-Controlled Analgesia. 2008;(June):3–9.  

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16. Appendices  
Appendix A: List of Anticipated Adverse Events 
In Table 5 a list of possible respiratory related adverse events occurring in high risk post-surgical patients 
is reported. 
In Table 6 a list of device related adverse events that may be possibly caused by the use of the devices 
required by this protocol is reported. 
Note that occurrence of RC markers alone, if patient is asymptomatic and no invasive actions are taken, 
are not considered as adverse events but would meet the primary endpoint definition. 
Table 5. Anticipated Respiratory Adverse Events 
Partial airway obstruction that required an NMBA antagonist
Respiratory Insufficiency that would require Non-invasive positive pressure ventilation, ambu 
bag mask assisted ventilation 
Respiratory failure that would require Invasive mechanical ventilation 
Upper airway obstruction requiring airway support measures (oral or nasal) such as intubation
or Laryngeal Mask Airway 
Respiratory insufficiency/failure that would require a transfer to the ICU 
Cardiopulmonary arrest
Death due to respiratory/pulmonary related complications
Table 6. Anticipated Device Related Adverse Events 
AE
Definition
Mitigation
Minor to moderate 
discomfort at finger 
sensor site or 
oral/nasal cannula 
site 
Minor to moderate discomfort/pain 
may be associated with application, 
presence or removal of study related 
sensors, or reaction to the standard 
adhesive with local irritation and 
redness or discomfort/pain related to 
sensor retention mechanism. 
The skin will be assessed before 
and after the application of the 
pulse oximetry sensors and 
nasal cannula site.   The design 
mitigation to reduce skin 
allergic reactions is the use of 
latex free, ISO 10993 compliant 
components.  Design of the 
oral/nasal interface and low 
pump suction pressure for 
sampling are means to reduce 
risk of discomfort. 
Itching (pruritus)
An abnormal sensation felt on the 
skin in a particular area. 
Pain (discomfort)
Subjective feeling of localized 
pain/discomfort 
Allergic reaction 
An abnormal reaction of the body to 
a substance, as acute onset of skin 
rash or erythema. 
The skin will be assessed before 
and after the application of the 
pulse oximetry sensors and 
nasal cannula site.   Patients 

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AE
Definition
Mitigation 
with known skin contact 
allergies to medical grade 
adhesives will not be recruited. 
 
 
 
 

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Appendix B: Alarm Management Protocol 
In the event of potential RC episodes, the nurse must assess the patient and identify the appropriate set 
of actions based on the patient’s condition.  
Criteria for notifying the patient’s physician or a respiratory therapist, decreasing or stopping the 
patient’s medication, administering a reversal agent, and/or using supplemental oxygen must be 
established by the hospital clinical team and included in the training protocol prior to the capnography 
monitoring implementation. Training must be provided to all nurses on the involved units, as well as 
respiratory therapists and rapid response nurses. The focus of education and training should include the 
significant clinical differences between monitoring a patient’s oxygenation (via pulse oximetry) and 
monitoring ventilation (via capnography). 
Recommended alarms setting during Study Phase II 
To facilitate the detection of RC episodes, the following alarm setting could be programmed at the 
beginning of the Study Phase II: 
Event 
Alarm threshold
Low  Respiration Rate 
≤ 8 bpm (>30 sec)
High  Respiration Rate 
≥22 bpm (>30 sec)
SpO2 /Hypoxemia
≤90% (>30 sec)
Low EtCO2
≤ 15 mmHg (>30 sec)
High EtCO2
≥60 mmHg (>30 sec)
Apnea
Apnea > 30 sec
IPI
IPI ≤3 > 30 sec
Each site will be free to modify the alarms setting according to specific patients’ needs or to decrease 
alarm-related burden. 
Alarm response and escalation policy 
Figure 1 provides an example of algorithm for responding to a respiratory monitor alarm. This could be 
used as starting draft if the site doesn’t have its own protocol. Threshold for escalation should also be 
defined by each site. 
There are different steps to be followed. 
1. Assess Patient: 
The bedside caregivers must be trained in reading respiratory monitored data and attentive to the 
respiratory warning signs.  
 
When the alarm sounds, first assess if the patient is breathing.  
1a) Is Patient arousable?  
Try to arouse the patient using the following methods:  

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 
Call patient’s name while stimulating him/her, such as shake shoulders, move arm, etc.  
 
Apply nail bed pressure.  
 
Perform a sternal rub.  
Is patient breathing?  
No: If the patient cannot be aroused, check if the patient is breathing. If the patient is not breathing, call 
Code immediately.  
Yes: If the patient is arousable and breathing, assess the patient’s breathing:  
 
Evaluate the patient’s breathing data (respiratory rate, quality, rhythm, and depth) over time to 
identify any gradual increase or decrease in respiratory rate, EtCO2 waveforms, and/or SpO2 
results.  
 
Assess the patient’s EtCO2 data with other patient data, such as medications, vital signs, etc.  
 
Think critically of what the numbers reflect the patient’s overall respiratory status.  
 
Evaluate any continuous IV infusion to rule out medication error.  
 
Check pump programming.  
 
Perform IV line reconciliation.  
1b) Is Patient Breathing Effectively?   
Yes: If patient is breathing effectively, re-assess patient per protocol.  
No: Call Rapid Response Team immediately and then:  
 
Contact provider (and keep informed).  
 
Consult respiratory care practitioner.  
 
Check medications.  
 Consider obtaining arterial blood gas.  
 
Consider administering reversal agent.  
 
Consider referral to a higher level of care.  
 
Consider initiating supplemental oxygen (and jointly provide an intervention to support 
ventilation).  
2. Is Alarm Valid?  
Yes: Go to Step 3  
No: If the alarm appears to be invalid, troubleshoot equipment:  
 
Fix/confirm correct placement of cannula and sensors on the patient.  
 
Analyze waveforms for irregularities.  
 
Check alarm parameters are appropriate for the patient.  
 Check for improper tube placement or equipment malfunction.  
3. Re-Assess Patient and Intervene (per Protocol)  
Regularly, re-assess patient (see Step #1 in Figure 1) and:  
 
Assess the patient’s respiratory rate, quality, rhythm, and depth for any early signs of 
hypoventilation.  

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 
Assess the patient’s vital signs trends for any indication of decompensation.  
 
Assess the patient’s pain and level of sedation, and consider adjusting opioid dose and/or 
frequency.  
 
Evaluate for Obstructive Sleep Apnea/sleep disorder.  
 
Consider obtaining authorization to initiate Non-invasive ventilation procedures, if needed. 
 
Figure 1. Respiratory Monitoring Alarm Response Algorithm. 
 
 
 

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Appendix C: List of Medications 
1.0 Medications 
1.1 Non-Opioid Analgesics 
1.3. Adjuvant Medications with Sedative 
Properties 
1.3.4. Anti- Convulsants 
 
Nonsteroidal Anti-Inflammatory 
Drugs  
 
COX-2 inhibitors  
 
Tramadol  
 
Acetaminophen 
1.3.1. Tricyclic antidepressants (TCAs) 
 
Amitriptyline  
 
Nortriptyline (Pamelor)  
 
Desipramine (Norpramin)  
 
Amoxapine 
 
Impramine  
 
Pregabalin (Lyrica) 
 
Gabapentin (Neurontin, Gabarone)  
 
Carbamezapine (Carbatrol, Equetro, 
Tegretol) 
1.2. Opioids 
 
 
1.2.1 IV Opioids 
   
 
Morphine 
 
Hydromorphone (Dilaudid) 
 
Fentanyl (Sublimaze, Duragesic) 
 
Meperedine (Demerol)  
1.3.2. Benzodiazepines 
 
Triazolam (Halcion) 
 
Temazepam (Restoril) 
 
Lorazepam (Ativan) 
 
Diazepam (Valium) 
 
Clonazepam (Klonopin) 
 
Alprazolam (Xanax) 
1.3.5. Antiemetics 
 
Diphenhydramine (Benadryl) 
 
Promethazine (Phenergan) 
 
Scopolamine (patch) 
 
Prochlorperazine  (generic) 
 
Dimenhydrinate (Dramamine) 
 
 
 
 
1.2.2. Oral opioids 
1.3.3. Sleep Aides 
 
1.3.6. Muscle Relaxants 
 
Hydrocodone (Vicodin, Lortab, 
Norco) 
 
Oxycodone (Roxicet, Percocet, 
Roxicodone) 
 
Fentanyl-transmucosal, sublingual 
(Actiq, Fentora, Onsolis) 
 
Methadone 
 
Tapentadol (Nucynta) 
 
Tilidine 
 
Zoldipem (Ambien) 
 
Ramelteon (Rozerem) 
 
Eszopiclone (Lunesta) 
 
____________________ 
 
1.3.3. Selective serotonin reuptake 
inhibitors 
 
Escitalopram (Lexapro)  
 
Fluoxetine (Prozac, Sarafem, 
Symbyax) 
 
Paroxetine (Paxil, Paxil CR, Pexeva)  
 
Sertraline (Zoloft) 
 
 Citalopram (Celexa)  
 
Cyclobenzaprine (Flexeril, Amrix)  
 
Metaxlone (Skelaxin)  
 
SOMA (Carisoprodol) 
 
Robaxin (Methocarbamol)  
 
Tizanidine (Zanaflex)  
 
Baclofen (Kemstro, Lioresal, and 
Gablofen)  
 
 
 

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Appendix D: American Society of Anesthesiologists Physical Status 
The American Society of Anesthesiologists (ASA) physical status classification is a grading system for 
assessing the health of patients before surgery. 
ASA PS 
Classification 
Definition 
Examples, including, but not limited to: 
ASA I 
A normal healthy patient. 
Healthy, non-smoking, no or minimal alcohol use. 
ASA II 
A patient with mild systemic disease. 
Mild diseases only without substantive functional 
limitations. Examples include (but not limited to): 
current smoker, social alcohol drinker, pregnancy, 
obesity ((30 < Body Mass Index (BMI) < 40)), well-
controlled Diabetes Mellitus (DM)/ hypertension 
(HTN), mild lung disease. 
ASA III 
A patient with severe systemic disease. 
Substantive functional limitations; One or more 
moderate to severe diseases. Examples include 
(but not limited to): poorly controlled DM or HTN, 
COPD, morbid obesity (BMI ≥40), active hepatitis, 
alcohol dependence or abuse, implanted 
pacemaker, moderate reduction of ejection 
fraction, ESRD undergoing regularly scheduled 
dialysis, premature infant PCA < 60 weeks, history 
(>3 months) of MI, CVA, TIA, or CAD/stents. 
ASA IV 
A patient with severe systemic disease 
that is a constant threat to life. 
Examples include (but not limited to): recent ( < 3 
months) MI, CVA, TIA, or CAD/stents, ongoing 
cardiac ischemia or severe valve dysfunction, 
severe reduction of ejection fraction, sepsis, DIC, 
ARD or ESRD not undergoing regularly scheduled 
dialysis. 
ASA V 
A moribund patient who is not expected 
to survive without the operation. 
Examples include (but not limited to): ruptured 
abdominal/thoracic aneurysm, massive trauma, 
intracranial bleed with mass effect, ischemic bowel 
in the face of significant cardiac pathology or 
multiple organ/system dysfunction. 
ASA VI 
A declared brain-dead patient whose 
organs are being removed for donor 
purposes. 
*The addition of “E” denotes Emergency surgery: (An emergency is defined as existing when delay in 
treatment of the patient would lead to a significant increase in the threat to life or body part). 

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Appendix E: ARISCAT, POSPOM and NEWS scores calculation 
ARISCAT risk score calculation14 
High or intermediate risk for postoperative pulmonary complications following abdominal surgery: 
ARISCAT risk score ≥ 26  
Risk for PPC of Variables Selected for the Logistic Regression Model 
  
Multivariate 
Analysis 
β Coefficients 
Risk 
Score§ 
OR (95% CI) 
  
N = 1624 
  
Age (yr) 
  
  
  
  ≤ 50 
1 
  
  
  51 – 80 
1.4 (0.6 - 3.3) 
0.331 
3 
  > 80 
5.1 (1.9 - 13.3) 
1.619 
16 
Preoperative SpO2, % 
  
  
  
  ≥ 96 
1 
  
  
  91 – 95 
2.2 (1.2 - 4.2) 
0.802 
8 
  ≤ 90 
10.7 (4.1 - 28.1) 
2.375 
24 
Respiratory infection in 
the last month 
5.5 (2.6 - 11.5) 
1.698 
17 
Preoperative anemia  
(≤ 10 g/dL) 
3.0 (1.4 - 6.5) 
1.105 
11 
Surgical incision 
  
  
  
  Peripheral 
1 
  
  
  Upper abdominal 
4.4 (2.3 - 8.5) 
1.480 
15 
  Intrathoracic 
11.4 (4.9 - 26.0) 
2.431 
24 
Duration of surgery, h 
  
  
  
  ≤ 2 
1 
  
  
  > 2 to 3 
4.9 (2.4 - 10.1) 
1.593 
16 
  > 3  
9.7 (4.7 - 19.9) 
2.268 
23 
Emergency procedure 
2.2 (1.04 - 4.5) 
0.768 
8 
  
Abbreviations: CI, confidence interval; OR, odds ratio;  
SpO2, oxyhemoglobin saturation by pulse oximetry breathing air in 
supine Position: PPC, postoperative pulmonary complications. 
† The simpliﬁed risk score is the sum of each logistic regression coefficient multiplied by 10, after rounding off its 
value.  
 

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POSPOM risk score calculation4 
POSPOM Score is an accurate risk score for predicting in-hospital mortality in patients undergoing 
surgery. 
 
 
 
TOTAL SCORE 
POSPOM <20: Average risk (less than 0.4% predicted risk) 
POSPOM=24: 3 times the average risk (1.2%) 
POSPOM=28: 10 times the average risk (4.2%) 
POSPOM=33: 40 times the average risk (16.5%) 

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LIFEGUARD Clinical Investigation Plan  
 
 
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NEWS score calculation24 
Criteria 
Point Value 
Respiratory Rate (breaths per minute) 
≤8 
+3 
9-11 
+1 
12-20 
0 
21-24 
+2 
≥25 
+3 
Oxygen Saturation (%) 
≤91 
+3 
92-93 
+2 
94-95 
+1 
≥96 
0 
Any Supplemental Oxygen 
Yes 
+1 
No 
0 
Temperature in °C (°F) 
≤35.0 (95) 
+3 
35.1-36.0 (95.1-96.8) 
+1 
36.1-38.0 (96.9-100.4) 
0 
38.1-39.0 (100.5-102.2) 
+1 
≥39.1 (≥102.3) 
+2 
Systolic BP 
≤90 
+3 
91-100 
+2 
101-110 
+1 
111-219 
0 
≥220 
+3 
 

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Heart Rate (beats per minute) 
≤40 
+3 
41-50 
+1 
51-90 
0 
91-110 
+1 
111-130 
+2 
≥131 
+3 
AVPU (Alert, Voice, Pain, Unresponsive)
A 
0 
V, P, or U 
+3 
 
A low score (NEWS 1–4) should prompt assessment by a competent registered nurse who should decide 
if a change to frequency of clinical monitoring or an escalation of clinical care is required. 
 
A medium score (i.e. NEWS of 5–6 or a RED score) should prompt an urgent review by a clinician skilled 
with competencies in the assessment of acute illness – usually a ward-based doctor or acute team 
nurse, who should consider whether escalation of care to a team with critical-care skills is required (i.e. 
critical care outreach team).  
o 
A RED score refers to an extreme variation in a single physiological parameter (i.e., a score of 3 on the 
NEWS chart in any one physiological parameter, colored RED to aid identification; e.g., heart rate 
 
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach 
team with critical-care competencies and usually transfer of the patient to a higher dependency care 
area. 
 
 

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4. Version History 
Version
Summary of Changes
Author(s)/Title
1.0, 24 Jan, 2018
Not Applicable, New Document
Nicoletta Grovale/Clinical 
Research Manager 
2.0, 19 Jun, 2019
Title Page: Updated address for Covidien 
Services Europe  
Section 2: Updated address for Covidien 
Services Europe. Updated expected total 
patient recruitment from 300 to 210; 70 
to be recruited in Phase I and 140 in 
Phase II. Updated Inclusion criteria No. 1 
to indicate that patients may be enrolled 
if the they have POSPOM score ≥ 24 OR 
ARISCAT score ≥ 26. 
Section 5: Updated expected total patient 
recruitment from 300 to 210; 70 to be 
recruited in Phase I and 140 in Phase II. 
Indicated that sites will have at least one 
month, as opposed to one week to 
familiarize themselves unblinded devices. 
Updated Figure 1 to reflect the above. 
Section 7.3: Updated Inclusion criteria 
No. 1 to indicate that patients may be 
enrolled if the they have POSPOM score ≥ 
24 OR ARISCAT score ≥ 26. 
Section 8.7: Updated to indicate that the 
point of patient exit from the study will 
not be the end of the monitoring period, 
but instead upon discharge from the 
hospital. Clarified that AEs are reportable 
during this period. 
Section 8.8: Updated to indicate that Date 
of patient discharge from hospital should 
be collected at study exit. 
Section 12.1: Updated total patient 
population from 300 to 210.  
 
Geraldine Kelly, Clinical Study 
Manager