The Impact of Enhanced Postoperative Vitals Monitoring In-hospital and at Home vs. Standard Care After Inpatient Abdominal and Vascular Surgery: A Pilot Two-centre Randomized Controlled Study
Phase: NA
Conditions: Surgery, Post Operative Complications, Quality of Recovery, General Surgery, Vascular Surgery, Urology, Gynecology
Sponsor: University of British Columbia

 
 
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The impact of enhanced postoperative vitals monitoring in-hospital and at 
home vs. standard care after inpatient abdominal and vascular surgery: A 
pilot two-centre randomized controlled study 
 
Short title: Enhanced postoperative vitals monitoring 
 
 
Study Protocol 
 
Principal Investigator:  
 
Janny Xue Chen Ke, MD, MSc, FRCPC, Department of Anesthesia, Providence Health Care; 
Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of medicine, University 
of British Columbia 
 
Co-Investigators:  
 
Su-Yin MacDonell, MD, FRCPC, Department of Anesthesia, Providence Health Care; 
Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of Medicine, University 
of British Columbia 
 
Charles V Yu, MD, FRCPC, Department of Anesthesia, Providence Health Care; Clinical 
Instructor, Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of medicine, 
University of British Columbia 
 
Jesse Greiner, MD, FRCPC, Division of General Internal Medicine, Department of Medicine, 
Providence Health Care 
 
Carl Brown MD MSc FRCSC, Department of Surgery, Faculty of Medicine, University of 
British Columbia, Vancouver, Canada 
 
Dr. Amandeep (Anu) Ghuman, MD MPH FRCSC, Department of Surgery, Faculty of Medicine, 
University of British Columbia, Vancouver, Canada 
 
Jason Sutherland, PhD, Centre for Health Services and Policy Research, School of Population 
and Public Health, The University of British Columbia, Vancouver, BC, Canada. 
 
Study Coordinators: Nicola Edwards 
 
Patient Partner: Renée Lukacs 
 
 

 
 
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1 Lay summary 
 
After surgeries, patients are at risk of a variety of complications. Close monitoring of vital signs 
may facilitate early detection and treatment of complications. However, the existing standard of 
care of intermittent monitoring in-hospital and no monitoring the first week after discharge may 
be too infrequent to capture vital sign derangements for early detection of complications. In this 
pilot randomized controlled trial, we will obtain preliminary data on whether enhanced 
monitoring of vital signs in-hospital and at-home makes a difference on patient morbidity and 
mortality outcomes, and report feasibility and logistics considerations for the design of a larger 
multi-centre randomized controlled trial. 
 
2 Background 
 
Background 
After surgeries, patients are at risk of a variety of complications, thus requiring monitoring for 
early detection and treatment of complications. The current standard of care consists of 
continuous monitoring of vital signs during and after anesthetic and/or in the high-acuity and 
intensive care units, followed by intermittent measurement of vital signs once the patient is in the 
ward. Once the patient is at home, there is no monitoring nor follow-up.  
 
However, it has been well-established that existing intermittent monitoring of vital signs are too 
infrequent to capture important vital sign derangements. For example, in an observational study 
of 312 patients who underwent abdominal surgery, 18% of patients had blood pressure <65 
mmHg for at least 15 minutes that were not detected by conventional intermittent monitoring1. 
Nevertheless, it remains unknown the optimal method and duration of increased monitoring for 
medium-to-high risk surgical patients in-hospital and at home. In a randomized controlled trial 
(RCT) involving 905 adults undergoing non-elective surgery, remote automated monitoring with 
virtual care did not reduce the number of days alive and at home 30 days after surgery (DAH30) 
compared to standard of care2. However, there are signals of increased detection of drug errors, 
decreased pain, and benefits in patients in centres with more escalations in care.   
 
3 Objectives  
 
3.1 
To obtain pilot data on the enhanced monitoring of vital signs in patients undergoing 
inpatient major abdominal (general surgery, urology, or gynecology) and vascular surgery, (i.e. 
continuous monitoring of vital signs in-hospital during the day time for three days 
postoperatively (POD0-POD3) followed by twice-daily monitoring at home for 3 days after 
discharge), with a protocol for care escalation if needed, compared to standard monitoring 
(intermittent monitoring in-hospital and no monitoring at home), on the following trial outcomes: 
a. Primary outcome: Days alive and at home within 30 days after surgery (DAH30) 
b. Secondary outcomes: 
i. Major morbidity (complications associated with 30-day mortality: major 
bleeding, myocardial injury after noncardiac surgery (includes myocardial 
infarction), myocardial infarction (3rd Universal Definition), sepsis, 
infection without sepsis, acute kidney injury with new dialysis, stroke, 

 
 
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venous thromboembolism and congestive heart failure3) within 30 days 
postoperatively  
ii. Mortality within 30 days postoperatively 
iii. Emergency visit after discharge within 30 days postoperatively 
iv. Readmission within 30 days postoperatively 
v. Urgent walk-in clinic visit within 30 days postoperatively 
vi. Family doctor clinic visit within 30 days postoperatively (not urgent walk-
in clinic) with details of planned (for suture/staple removal, or other 
reason) vs. unplanned 
vii. Surgeon visit (with details of method [email, phone call, or clinic visit] vs. 
in-person [planned vs. unplanned]) 
viii. Postoperative length of stay  
ix. Quality of recovery (QoR-15 questionnaire) on 14 and 30 days 
postoperatively (patients will do baseline questionnaire at study 
enrollment) 
 
3.2 To explore the feasibility of the intervention of enhanced monitoring of vital signs in 
patients undergoing inpatient major abdominal (general surgery, urology, or gynecology) 
and vascular surgery. The primary feasibility outcome is defined as >80% completion of the 
monitoring protocol; with a priori definition of the completion being 3 blood pressure 
readings per day for 3 days in-hospital (or the duration of the hospital stay, whichever is 
shorter) and at 2 times a day at home each for 2 times a day for 3 days The additional 
feasibility outcomes are  
c. Participation measures (recruitment and retention rates) 
d. Acceptability 
i. patient use of the monitoring devices (frequency, duration, problems 
encountered, reason for discontinuation) 
ii. patient feedback about enhanced monitoring (Systems Usability Scale 
questionnaire at the end of the monitoring intervention in hospital and at 
home) 
e. Clinical resource utilization (frequency and type of vital sign derangements 
detected by enhanced monitoring and the resulting care escalation from the start 
to the end of the monitoring intervention), time between vital sign alert and care 
escalation, logistics of device use (time spent on education, initiation, 
discontinuation, cleaning, collection, and troubleshooting of devices), issues that 
arise in the workflow 
f. Evaluation of potential harm or safety issues (mobility and anxiety questions at 
the end of the monitoring intervention in hospital and at home) 
3.3 Logistics of the study questionnaires: completion rates, method of completing the 
questionnaires, caregiver and technical support required  
 
Findings from both the trial and feasibility outcomes will inform the design of a future large-
scale multicentre trial. The DAH30 outcomes data will allow the estimation of precision for 
future sample size calculation.  
 
 
 

 
 
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4 Methodology 
 
4.1 Design and Setting 
 
This study is a single-blinded, parallel-group, pilot RCT, with an exploratory feasibility analysis. 
The study will be registered on ClinicalTrials.gov prior to patient recruitment, and reported 
according to the Consolidated Standards of Reporting Trials (CONSORT) pilot RCT standards4.  
 
The study will be conducted at St Paul’s Hospital (SPH), Providence Health Care, in Vancouver, 
BC, Canada, an academic tertiary care hospital affiliated with the University of British 
Columbia. Based on data from Jan 2022 to Aug 2023, the volume of inpatient general 
surgery is 107 per month, with a median postoperative length of stay (LOS) of 3 days, ER 
visit rate of 13%, and readmission rate of 6%. The volume of inpatient vascular surgery is 
11 per month, with a median postoperative LOS of 5 days, ED visit rate of 10%, and 
readmission rate of 6%.  
 
The SPH anesthesia and surgical program already has a strong perioperative care focus, featuring 
enhanced postoperative support available for high risk patients including 1) surgical high-acuity 
unit (SHAU) with continuous monitoring, run by anesthesiologists, 2) Perioperative Outreach 
Team that rounds on patients daily for as long as clinically indicated, run by anesthesiologists, 3) 
multidisciplinary collaboration and support from perioperative internal medicine and/or geriatric 
teams, with daily rounding for as long as clinically indicated and availability for preoperative 
consultation and post-discharge follow-up in rapid access clinics, and 4) protocolized monitoring 
for myocardial injury after non-cardiac surgery for three days according to the Canadian 
Cardiovascular Society guidelines5.  
 
4.2 Inclusion criteria 
a. Aged 19 years or older 
b. Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or 
vascular surgery at St. Paul’s Hospital (SPH) and Mount Saint Joseph (MSJ) Hospital 
c. Length of stay is at least 48 hours (planned by the clinical team, or by the Canadian 
Institute of Health Information Discharge Abstract Database Expected Length of Stay 
(ELOS) for the surgical case mix group) 
d. Self-reported fluency in reading and speaking in English 
e. Living within British Columbia, Canada and in an area that is covered by Bell cellular 
network (the Cloud DX device has cellular LTE using the Bell network).  
 
4.3 Exclusion criteria 
a. Patient refusal  
b. Transplant surgery, since these patients have a unique set of considerations and 
postoperative course.  
c. Inability to communicate with research personnel, perform self-monitoring of vital signs, 
or complete study surveys due to cognitive, language, visual, or hearing barriers  
d. Lack of capacity to consent to the study (including under the active influence of sedative 
medication or having received general anesthetic within the past 24 hours)  
e. Unable to use (or does not have a caregiver who can help put on/take off) study 
monitoring device at home  

 
 
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f. Preoperatively known planned discharge to a nursing home or rehabilitation facility 
g. Patient with known allergic reactions to any part material of the device 
h. Unable to monitor blood pressure accurately noninvasively using arm blood pressure 
cuffs, such as due to underlying vascular anatomy or non-pulsatile blood flow physiology 
i. Unlikely to be able to return the home monitoring kit (no fixed address, living too far 
away from site, etc.) 
 
4.4 Recruitment and Consent  
An initial list of patients will be obtained daily from the hospital’s operating room schedules 
(including patients who are on the emergency room waitlist), surgeon’s clinic schedules 
(vascular and abdominal surgery), and the anesthesia preadmission clinic schedule, accessible 
through Cerner. The table below indicates the locations where patients undergoing elective vs. 
urgent/emergent surgeries will be approached preoperatively. No recruitment will be done 
postoperatively.  
   
Table. Potential locations and points of approach 
Urgent/Emergent surgery  
Elective surgery 
Ward  
Operating room holding area (where 
patients from the ward may wait prior to 
going to the operating room) 
SHAU 
Anesthesia preadmission or surgeon 
clinics (in-person or phone call) 
Surgical Day Care  
Ward (if admitted to the ward 
preoperatively) 
 
The study coordinator will review the patient’s chart on Cerner and screen the patients against 
the inclusion and exclusion criteria of the study to identify those who are eligible. The research 
team will confirm that the patient has agreed to a member of the patient’s circle of care that they 
are amenable to being approached about research.  Once this approval is confirmed, the study 
coordinator will approach the patient, explain the study, answer questions, and obtain the written 
consent. Each participant will receive a copy of the consent for their record. For patients whose 
preoperative clinic visits are through Telehealth, the consent form will be read on the phone 
and/or emailed to the patient by the research team. If the patient agrees to participate, a verbal 
consent will be obtained. The written consent will be signed preoperatively when the patient is in 
the hospital for the surgery.  
 
4.5 Randomization  
Randomization is conducted after informed written consent has been obtained from a patient 
who is eligible to the study. Participants will be randomized 1:1 to either the intervention group 
or the control group (standard of care), stratified by sex. The computer-generated random 
allocation sequence will be created by Centre for Advancing Health Outcomes, Providence 
Health Care, who has no involvement in any other research activities of the study. The algorithm 
will be administered through the Cerner Careflow research interface. There will be 12 blocks of 
4 and 8 blocks of 6 in random order, with n = 96 patients per strata (the total sample size is n = 
110, per sample size calculation section below).  
 
4.6 Blinding 
In order to prevent the treating physicians from adjusting patient disposition to the ward on the 
assumption that the patient will have increased monitoring as part of the study, blinding will be 

 
 
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done to the care team and patient until the patient has been ordered to be medically transferred to 
the ward from the recovery room, high acuity unit, or intensive care. The intervention to 
increased monitoring vs. standard of care will only be unveiled at that point, and the intervention 
arm patients will be placed on increased monitoring monitors at that time. Blinding is not 
possible to the patient on the ward due to the nature of the intervention (more frequent 
monitoring). Blinding is not possible to the ward care team and outcome assessors due to the 
potential need for care escalation from enhanced monitoring. The data analyst analyzing the 
primary and secondary outcomes will not be involved in the rest of the study conduct 
(recruitment, consent, data collection, and data cleaning) and will be blinded to the group 
assignment which will only be unmasked once the data analysis is submitted to the Principal 
Investigator. The feasibility outcomes will be analyzed by a separate data analyst, as most of the 
outcomes are within the intervention group and blinding will not be possible.  
 
4.7 Control Group 
Participants in the control group receive the standard of care monitoring after the surgery as 
prescribed per the care team at St. Paul’s Hospital, according to the patient’s needs. Monitoring 
as deemed by the care team will never be withheld from the patient for any study purpose (e.g. if 
clinically needed the patient in the control group will receive continuous monitoring in HAU 
and/or ICU per standard of care). Appendix A. shows the monitoring guidelines for 
postoperative patients (i.e. to the most frequent monitoring required by the clinical situation), 
adopted from the current nursing protocols at SPH and MSJ. Vital signs measured are blood 
pressure (BP), heart rate (HR), temperature (T), respiratory rate (RR), oxygen saturation (SpO2), 
Pasero Opioid Sedation Scale (POSS), and pain assessment (Pain), and are documented in 
Cerner automatically from the monitor and/or manually. Since end-tidal carbon dioxide 
monitoring is not part of the study objectives, patients on the sleep apnea protocol will continue 
to receive extended Post Anesthetic Care Unit (PACU) stay and end-tidal carbon dioxide 
monitoring per standard of care. Once the patient is discharged from the hospital, the current 
standard of care is no monitoring of vital signs at home.  
 
4.8 Intervention Group 
Patients randomized to the intervention group will receive enhanced (i.e. additional) 
monitoring using Health Canada approved devices in-hospital during the day for three days 
after surgery (POD0-POD3 inclusive) or until discharge, whichever occurs first, followed by 
twice-daily monitoring at home for 3 days after discharge, with a protocol for clinical 
escalation if vital sign alert thresholds are exceeded. Except for the increased frequency of 
monitoring, all aspects of the patient’s care will be per standard of care (e.g. the study has no 
impact on the decision to discharge home). The table below has the detail of the enhanced 
monitoring.  
 
Table. Enhanced (additional) monitoring parameters  
Patient location  
Monitoring frequency 
Monitoring device  
In hospital (PACU, 
HAU, ICU) 
No study monitoring will occur as standard of care monitoring (See 
Appendix A.) is the same or more frequent. 
In hospital (ward) 
8am – 5pm 
HR and SpO2: continuously 
Noninvasive BP: 
automatically q60 minutes  
Philips Intellivue M450 
monitors (same as what is used at 
the SPH PACU) with Nellcor.  

 
 
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At home (discharged) HR, SpO2, noninvasive BP: 
two times a day (approx.. 
once during 8am-12:30pm, 
and 12:31pm-5pm) 
Temperature (once daily) 
 
CloudDX Kit 
(includes blood pressure monitor, 
pulse oximeter (HR and SpO2), 
thermometer 
Note: Vital signs from the study monitors will be transmitted securely to the PHC CareFlow 
 
In hospital, while the study patients are encouraged to keep the monitoring on whenever is 
reasonable to the patient, the patient and medical circle of care team can pause or terminate the 
enhanced monitoring for any reason (e.g. mobilization, physiotherapy, toileting, shower, meals, 
and naps), and this will be documented in the patient study diary. A patient can connect or 
disconnect as often as they wish. Patients and caregivers will be educated how to put on and off 
the devices by the research coordinator. If there is any issue, the study coordinator will visit the 
patient and assist. The regular clinical care team is not expected to assist with the study device. 
The Philips monitor study device used in hospital is the same as the monitor that is being used in 
the SPH PACU. The nurses within the circle of care do not need to be involved in the setup, 
monitoring, troubleshooting, nor removal of the study devices.  
 
Importantly, patients in the intervention group will still receive all monitoring as deemed 
necessary by the standard of care, and monitoring will never be withheld from the patient as 
clinically indicated. For example, the patient may receive continuous HR, SpO2, and arterial BP 
monitoring in the SHAU, operating room (e.g. during a reoperation), or ICU. If the clinically-
indicated monitoring per standard of care is equal or greater than the frequency listed in the 
below table, the patient does not need to use the study device nor clinical escalation - i.e. the 
existing monitor in SHAU, operating room, or ICU would be sufficient, and the research 
coordinator will not monitor the alerts, since this will already be done by the treating team as the 
standard of care. To summarize, if any of the components from the standard of care are exactly 
the same as or more than what the enhanced monitoring provides (e.g. patient already has a 
functioning arterial line as part of the standard of care), then the patient will not require the 
additional study monitors (unless the patient still needs the study monitor for another vital sign). 
 
The circle of care will not have access to the data from the enhanced monitoring. If the alert 
thresholds are reached per the following table (guided by the NEWS2 score), an alert will be sent 
to the study cell phone by text messaging and by study email with the de-identified study ID and 
type of abnormal vital sign. For consistency and safety, the thresholds will not be adjusted for 
individual patients in this study.  
 
To avoid the excess of alerts that are not related to clinically relevant events for patients, the alert 
to the study coordinator will be sent if the vital sign remains abnormal for 1 minute or more 
when the vital signs is monitored continuously (HR and SpO2). The study personnel will only 
alert the patient’s care team if the vitals are worse than what is already documented on Cerner 
and worse than the previous alert (i.e. if the patient’s systolic blood pressure has been 90mmHg 
and the patient’s care team was already previously alerted about this, the patient’s care team will 
not be alerted again. However, if the systolic blood pressure is now 80mmHg, then the patient’s 
care team will be alerted). The study monitors will be silenced as to not disturb the patient or the 

 
 
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care team, but all derangements that are new and not already documented in Cerner will be 
notified to the care team.  
 
Vital sign 
Thresholds for alert  
Systolic BP (mmHg) 
<=100, or >=220 
Saturation of Peripheral Oxygen (SpO2) (%) for non-COPD patients 
<=93 
Saturation of Peripheral Oxygen (SpO2) (%) for COPD patients (if 
they have been prescribed a COPD-specific threshold of 88-92% 
while in hospital) 
<=87, or >=93 on oxygen 
Heart Rate (HR) (beats per minute) 
<=50, or >=91 
Temperature (at home) 
<=36.0 or >=38.1 
 
The research coordinator will review the alerts in the above table between 8am and 5pm, for the 
day of surgery until 3 days after surgery (POD0-POD3) in hospital and the first 3 days at home 
after discharge from the hospital. The role of the research coordinator is to triage according 
to the escalation protocol, alert patients and refer to standard of care, but not provide 
further clinical assessment nor treatments (i.e. it would be similar to if a patient does a BP at a 
pharmacy and it's abnormal, what resources the patient has access to). The research coordinator 
will consult with the study team physicians if there is any uncertainty.  
 
• If the patient is in-hospital, the study personnel will first check Cerner to see if the 
abnormal vital sign is already documented within the past hour. If so, no contact with the 
care team is needed, since the same vital sign is already known to the care team per 
standard of care and the intervention do not contain additional information that will 
change care. If the abnormal vital sign is not documented in Cerner, the study personnel 
will contact the patient’s main care team regarding the vitals, and the care escalation will 
be according to the existing standard of care per the circle of care. Note the study 
personnel will not engage with the care team beyond the initial notification to the care 
team.  
• If the patient is at home, the study personnel will contact the patient (or if the patient 
cannot be reached after 3 tries by phone, then the emergency contact up to 3 times) within 
2 hours of the alerts. The recommendation from the research coordinator for all patients 
with alerts is to call the BC 811 nursing line and go to the urgent care clinic or ER to be 
assessed. Patients will be informed why they need to go (the abnormal vital[s]), why it is 
important to go and what are the consequences for not going. There will be no further 
clinical assessment from the research coordinator, as this is not the standard of care.  
• The patient will also be provided a handout for what is normal and what is abnormal for 
vital signs per NEWS2 at the same moment of providing the home device. The care team 
may contact the study physicians during day time hours (8am to 5pm) about further 
questions. At any time, all outpatients have access to standard of care: day time e.g. 
surgeon's office numbers, ERAS patients have access to the ERAS nurse who calls them 
within 24h and can be contacted by phone/email for a week, FP/NP; night time e.g 811, 
ER, urgent care. While we provide 9 hour monitoring to alert the patients if the vital signs 
are outside of the usual range, patients may still be having issues that may not lead to 
abnormal vital signs and the research coordinator may not receive an alert. Patient should 
still monitor for symptoms and reach for help as instructed by their hospital team at 

 
 
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discharge, and contact the standard of care team with any concerns/issues even if there 
are no abnormal signs. 
• Once a patient is labeled with Awaiting Long-term Care status per PHC standard of care, 
they will be considered at home and will be given the CloudDX devices even when they 
are in hospital. If needed, the research coordinator will help the patient with the 
measurements.  
 
The notification of the care team in-hospital and patient/caregiver at home will be documented 
within the study data collection form. The escalations required (table below) will be documented 
by a combination of asking the patient’s care team their next course of action, referrals required, 
and/or chart review. Multiple escalations may apply for the same patient, at multiple time points.  
 
To facilitate the tracking of in-hospital vital signs derangements, alerts and their corresponding 
escalation, the study personnel will provide an escalation report sheet, that will be attached to the 
patient’s monitor. Care Team will record the date, time, abnormal vital sign and escalation made 
after every abnormal vital sign notification. 
 
4.8.1 Clinical escalation protocol 
 
If there are no alerts, no escalation will occur, regardless of location. If there is an alert, while in 
hospital, the study team and/or care team will confirm that it is not an error. If it is an error, it 
will be documented as an artifact measure. The table below describes the protocol for escalation. 
The care team will be asked to record and specify if any escalation occurred. 
 
Table. Definitions of escalation types  
Definition  
In-hospital 
At Home  
Escalation  The patient’s care team: 
1. Performed an action as a direct result of the 
additional information (e.g. remind OSA patient 
to take a deep breath, will check in with the 
patient more closely, cycled vitals or will cycle  
vitals that were not planned prior to the alert) 
2. Informed the most responsible physician or 
designate   
3. Ordered additional testing (e.g. lab, imaging) 
4. Ordered additional therapy (e.g. medication, 
oxygen, intubation, surgery) 
5. Had a Physician assess the patient in-person,  
6. Moved the patient to a higher acuity ward (e.g. 
SHAU, ICU), 
7. Called Critical care outreach team or 
perioperative outreach team  
8. Consulted specialist 
9. Other (specify) 
The Research Team: 
 
Advised patient or 
caregiver by phone to 
call the BC 811 nursing 
line and/or go to urgent 
care clinic or ER to be 
assessed. (contact will 
be attempted 3 times) 
 
4.9 Device Teaching, Initiation, Removal, and Collection  
The study personnel will check the data stream daily to ensure no issues and to make sure the 
device is functioning. The study coordinator will email the Cloud DX Support team with 

 
 
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patient's discharge date and patients will be contacted some time between 10-2pm the day of 
discharge (unless the patient prefers another time).  The Cloud DX technical team will reach out 
to participants to support the use of the home monitoring devices. Cloud DX will also call 
patients between 11am and 1pm to remind them to take measurements if a set of measurements 
is missed. Appendix B. lists the logistics of the study devices and Appendix C describes the 
device components.  
 
4.10 Outcomes 
 
4.10.1 Trial outcomes 
Appendix D lists the detailed outcome definitions. 
 
a. Primary trial outcome:  
i. 
Days alive and at home within 30 days after surgery – DAH307 
 
b. Secondary trial outcomes from both the intervention group and the control group 
ii. 
Major morbidity, as defined by complications associated with 30-day mortality: 
major bleeding, myocardial injury after noncardiac surgery (includes myocardial 
infarction), myocardial infarction (3rd Universal Definition), sepsis, infection 
without sepsis, acute kidney injury with new dialysis, stroke, venous 
thromboembolism and congestive heart failure within 30 days postoperatively  
iii. 
Mortality within 30 days postoperatively 
iv. 
Emergency visit after discharge within 30 days postoperatively 
v. 
Hospital readmission within 30 days postoperatively 
vi. 
Urgent walk-in clinic visit within 30 days postoperatively 
vii. 
Family doctor clinic visit within 30 days postoperatively (not urgent walk-in 
clinic) with details of planned (for suture/staple removal, or other reason) vs. 
unplanned 
viii. 
Surgeon visit (with details of method [email, phone call, or clinic visit] vs. in-
person [planned vs. unplanned]) 
ix. 
Postoperative length of stay  
x. 
Quality of recovery (QoR-15 questionnaire) on 14 and 30 days postoperatively 
(patients will do baseline questionnaire at study enrollment)  
c. Secondary trial outcomes from the intervention group only 
xi. 
Characterize quantitatively and qualitatively vital sign derangements (extent, 
frequency, clinical impact) detected through continuous vitals monitoring that 
were missed by standard of care monitoring (i.e. what is documented in Cerner) 
xii. 
Characterize the type of care escalations required as a result of the additional data 
from continuous vitals monitoring  
4.10.2 Feasibility outcomes 
 
a. Participation measures 
i. 
# of patients meeting the clinical inclusion criteria 
ii. 
# of patients excluded and the reasons, based on the exclusion criteria 
iii. 
# of patients approached for recruitment 
iv. 
# of patients provide consent 
v. 
# of patients withdrawal 

 
 
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b. Acceptability 
vi. 
patient use of the devices (frequency, duration, problems encountered) 
vii. 
what were the reasons that patients took the monitors on and off (e.g. 
charging/battery life, showers, eating, mobilization/physiotherapy) – patient 
daily log sheet  
viii. 
Instances of interruption in monitoring > 4 hours  
ix. 
patient feedback about enhanced monitoring (Systems Usability Scale once at 
the end of the in-hospital monitoring and again at the end of the home 
monitoring, with the questionnaire being open for 1 week for patients to 
complete) 
 
c. Clinical resource utilization 
x. 
frequency and type of vital sign derangements detected by enhanced monitoring 
and the resulting care escalation within the duration of monitoring 
xi. 
time between vital sign alert and care escalation 
xii. 
logistics of device use (time spent on education, initiation, discontinuation, 
cleaning, collection, and troubleshooting of devices) 
xiii. 
issues that arise in the workflow 
 
d. Evaluation of potential harm or safety issues  
a. Any patient-reported adverse events  
b. Feedback questionnaire filled out by the patient at the end of enhanced monitoring 
in hospital and at home 
i. To what extent did the enhanced monitoring affect your ability to move 
around after surgery? (Likert scale) 
ii. To what extent did the enhanced monitoring affect your daily activities 
(e.g. going to the bathroom, eating, showering) ability to move around 
after surgery? (Likert scale) 
iii. To what extent did the enhanced monitoring make you anxious about your 
health? (Likert scale) 
 
e. Cost analysis 
xiv. 
Study costs (for planning for multicentre study) 
xv. 
Compared to standard of care group (staffing, healthcare utilization, equipment) 
 
4.10.3 Logistics of the study questionnaires 
a. completion rates 
b. method of completing the questionnaires 
c. caregiver and technical support required  
 
4.11 Data Collection 
 
Data will be collected through the following methods:  
(1) PHC Cerner: A data dictionary file will be provided to the PHC analytics team to set up the 
automated data extraction from Cerner. The time range of the data to be extracted is from one 

 
 
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month prior to hospital admission to 31 days after surgery. Extracted data will be transferred to 
PHC CareFlow platform for storage, filtering and downloads.  
 
(2)  Chart review: For clinical data that is not available through the automated data extraction 
from Cerner or is available but extracted with error, the research coordinator will conduct chart 
reviews to collect or verify data. 
 
(3) CareFlow: Vital signs data captured by the enhanced monitoring devices (Philips in hospital 
and Cloud DX at home) will be transmitted to PHC CareFlow for storage and downloads. 
 
(4) Questionnaires: Participants in both groups will be asked to complete two questionnaires: 
Enrollment Questionnaire for demographics, and the Quality of Recovery (QoR-15) 
questionnaire preoperatively and on the 14th day and 30th day after surgery. QoR-15 is a 15-item 
short survey to evaluate the early postoperative health status of patients. Additionally, 
participants in the intervention group will be asked to complete the following questionnaires: (a) 
Daily log sheet while they are under the enhanced monitoring in hospital and at home. The daily 
log includes questions regarding the utility of the study devices, such as how long and how often 
participants use the devices, reasons for taking off, and any concerns or issues about the usage. 
(b) Systems Usability Scale (SUS) at the end of enhanced monitoring in hospital (POD4 or 
discharge, whichever is earlier) for Philips monitor and at the end of enhanced monitoring at 
home (post-discharge day 4) for CloudDx. This is a simple, 10-item scale to evaluate 
participants' assessments of the device usability. (c) Feedback on Enhanced Monitoring 
Questionnaire at the end of enhanced monitoring in hospital (POD4 or discharge, whichever is 
earlier) for Philips monitor and at home (post-discharge day 4) for CloudDx. This questionnaire 
is composed of three Likert scale questions regarding adverse reactions from the monitoring 
intervention, as well as an open text field where patients can write more detail. Participants will 
be offered with options to complete the questionnaires online (through UBC REDCap), through 
telephone with research coordinator, on hard copies. Those choosing the hard copies will be 
asked to take photos of their answers and email to the research coordinator prior to mailing the 
questionnaires back using the return envelopes. 
 
(5) Phone call follow-up: The research coordinator will call participants in both groups on the 
postoperative day 31 or later to verify study outcomes, such as hospital readmission, emergency, 
urgent care or family doctor clinic visits, and major morbidity, particularly when these variables 
cannot be obtained by chart review.    
 
Table: Questionnaires used in the study 
 
Questionnaire 
Group  
Time point of measurement 
Enrollment 
questionnaire  
Both 
At enrollment, after randomization 
QoR-15 
Both 
Preoperative, POD 14 & POD 30 
Daily Log Sheet 
Intervention 
Daily while under enhanced monitoring (Postoperative days 
0 to 3 or discharge, whichever comes first) in hospital, and at 
home post-discharge days 0 to 3 for Cloud Dx Kit 
SUS 
Intervention 
Postoperative day 4 or discharge, whichever comes first, for 
Phillips), and at home post-discharge day 4 for Cloud Dx 

 
 
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Feedback 
questionnaire 
Intervention 
Postoperative day 4 or discharge, whichever comes first, for 
Phillips), and at home post-discharge day 4 for Cloud Dx 
 
 
4.12 Honorarium 
Patients will receive a $40 gift card which will be distributed at the time when the research 
coordinator makes the last phone call with the patients to collect the final data around secondary 
outcomes within 30 days postoperatively. At the end of the phone call, patients will be offered 
with options to receive the gift card by email or by taking the claim code over the phone.  
 
4.13 Analysis Plan  
 
4.13.1 Pre-processing 
Data from study questionnaires, chart review, Cerner data pull, and Careflow data pull will be 
linked by study ID.   
 
4.13.2 Missing data  
The % missing values for each variable will be quantified and reported.  
 
4.13.3 Cohort characteristics  
a. Patient (demographics, medical, and surgical factors)  
i. 
Age, gender, ethnicity, height, weight, body mass index (BMI), NT-proBNP, 
troponin 
ii. 
Reason(s) for perioperative team follow up 
iii. 
RCRI score and components, ASA score, components and total score for 
Charleson Comorbidity Index [via Cerner-CIHI DAD extraction and also 
manually confirmed via chart review] 
iv. 
Urgency of procedure 
v. 
Surgical service  
vi. 
Admissions to HAU/ICU 
vii. 
demographic predictors of nonparticipation and reasons for early drop outs, 
and how we can support them (e.g. phone connectivity, language issue, 
discomfort) 
viii. 
Total operation time 
ix. 
Reoperation(s) (with postoperative day information) 
b. Type(s) of clinical escalation and timeline [copy from Outcome section above] 
c. Morbidity and mortality  
x. 
Length of stay and days alive and at home 30 days after surgery  
xi. 
Mortality  
xii. 
Postoperative complications  
xiii. 
Healthcare utilization (ED, readmission, reoperation)  
xiv. 
Discharge destination  
d. Characterize quantitatively and qualitatively vital sign derangements (extent, 
frequency, clinical impact) detected through continuous vitals monitoring that were 
missed by standard monitoring 
e. Characterize the type of care escalations required as a result of the additional data 
from continuous vitals monitoring. Escalation will be further characterized as using 

 
 
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i. Per person rate and extent of change in clinical management because 
of the continuous data 
ii. Timeframe (hours) of each step of escalation  
f. Quantitative data on how long and how often did patients use this monitoring 
g. Qualitative data (through patient study diary) on what were the reasons that 
patients took the monitors on and off (e.g. charging/battery life, showers, eating, 
mobilization/physiotherapy)  
h. Staffing requirements for device use (time spent teaching, putting devices on, 
taking devices off, collecting devices, education of perioperative and ward nurses)  
 
4.13.4 Analysis of outcome  
The rates of outcomes will be reported. The median (IQR) or mean (SD) of DAH30 will be 
reported, depending on the distribution. Since this is a pilot study, no tests of significance will be 
performed. Intention-to-treat will be used, with a per protocol sensitivity analysis.   
 
For patient outcomes, the effect size will be estimated using univariable and multivariable 
analyses (logistic regression for binary outcomes and generalized linear model for continuous 
outcome). The planned a priori variables adjusted in the multivariable models are age, sex, 
surgical urgency and surgical service.  
 
4.13.5 Questionnaire data 
Descriptive statistics of questionnaire results will be performed.   
 
4.13.6 Sample Size 
Based on the below recommendation from Advancing Health, PHC, the sample size will be n = 
100 (n = 50 per group). Accounting for a drop out rate of 10%, we will recruit n =110.  
 
As a feasibility study, it is recommended that the sample size considerations be based on an 
acceptable precision for the feasibility outcomes of interest, often expressed as the width of a 
confidence interval for specific endpoints. While it can be given some consideration, the sample 
size for a feasibility study should not be based on a clinical outcome of interest.i  
 
For a range of sample sizes, the following table lists the range of confidence interval widths for 
an endpoint expressed as a proportion (eg. % of participants who complete the study).  For 
outcomes expressed as a proportion, confidence intervals are widest when the proportion is 
around 0.5 and gets narrower as the expected proportion decreases/increases to close to 0 and 1.   
 
The interpretation is: With X participants per arm we would be able to estimate the proportion of 
participants who completed the study with a maximum confidence interval width of Y (in each 
arm); where X and Y are read from the appropriate row of the table.   
 
 
Sample 
Size/arm 
95% Confidence Interval Width 
Minimum 
Maximum 
 
i Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 
2022 Jan 1;60(1):95-103.PMID: 34812790 

 
 
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(proportion 
~0.1/0.9) 
(proportion 
~0.5) 
30 
0.24 
0.37 
40 
0.21 
0.32 
50 
0.18 
0.29 
60 
0.17 
0.26 
 
The data collected during a feasibility study can be used to gather data to allow for an accurate 
measure of variability in a clinical outcome of interest in the specific study population.  It may be 
useful to report a possible confidence interval limit for a clinical outcome in support of the 
chosen sample size based on the feasibility outcome. In the table below, the estimated width of a 
confidence interval for the outcome number of days at home alive up to 30 days (DAH30) has a 
reported using standard deviations reported in different sources.  Where the data were reported as 
median and IQR, the ‘rule of thumb’ estimate of (75th%ile – 25th%ile)/1.35 was used.ii   MCID of 
DAH30 has been reported as 3 days.iii 
 
Sample 
Size/arm 
95% Confidence Interval Width 
Jareth et aliv 
IQR=24-27 -> 
SD~2.2 
McGillon et al v 
SD=3.9 
Bell et alvi 
IQR=23-29 -> 
SD~4.4 
30 
1.64 
2.91 
3.28 
40 
1.41 
2.49 
2.81 
50 
1.25 
2.22 
2.50 
60 
1.14 
2.01 
2.72 
 
In a non-feasibility study, the usual interpretation of the above information would be: with 40 
participants per arm if the SD of the outcome is 2.2 in each arm the study would have 80% 
power to detect a difference of 1.4 DAH30.  If the SD of the outcome is 4.4, the detectable 
difference is 2.8.   
 
In a feasibility study, usually only estimates with confidence intervals are reported; statistical 
comparisons between groups are not conducted.  
 
 
 
 
ii Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions. 2008, Wiley Online Library 
iii Ferguson MT, Kusre S, Myles PS. Minimal clinically important difference in days at home up to 30 days after 
surgery. Anaesthesia. 2022 Feb;77(2):196-200. Epub 2021 Nov 19. PMID: 34797923. 
iv Jerath A, Austin PC, Wijeysundera DN. Days Alive and Out of Hospital: Validation of a Patient-centered Outcome 
for Perioperative Medicine. Anesthesiology. 2019 Jul;131(1):84-93. PMID: 31094760. 
v McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, et al; PVC-RAM-1 Investigators. Post-discharge 
after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard 
care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. PMID: 34593374 
vi Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated 
and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-
26.PMID: 31317130 

 
 
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References 
1.  Turan A, Yang D, Bonilla A, Shiba A, Sessler DI, Saager L, et al. Morbidity and mortality 
after massive transfusion in patients undergoing non-cardiac surgery. Can J Anesth Can 
Anesth. 2013 Aug 1;60(8):761–70.  
2.  McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, et al. Post-discharge 
after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology 
versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209.  
3.  Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Study 
Investigators, Spence J, LeManach Y, Chan MT, Wang CY, Sigamani A, et al. Association 
between complications and death within 30 days after noncardiac surgery. CMAJ Can Med 
Assoc J J Assoc Medicale Can. 2019 Jul 29;191(30):E830–7.  
4.  Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 
2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 
24;355:i5239.  
5.  Pelland A, Chau A, Shin HJ, Prabhakar C. Improving adherence to a monitoring protocol for 
myocardial injury after non-cardiac surgery. Can J Anesth Can Anesth. 2020 Oct 
1;67(10):1475–7.  
6.  Vernooij JEM, Koning NJ, Geurts JW, Holewijn S, Preckel B, Kalkman CJ, et al. 
Performance and usability of pre-operative prediction models for 30-day peri-operative 
mortality risk: a systematic review. Anaesthesia [Internet]. [cited 2023 Mar 10];n/a(n/a). 
Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/anae.15988 
7.  Jerath A, Austin PC, Wijeysundera DN. Days Alive and Out of Hospital: Validation of a 
Patient-centered Outcome for Perioperative Medicine. Anesthesiology. 2019 Jul 
1;131(1):84–93.  
8.  Southern DA, Burnand B, Droesler SE, Flemons W, Forster AJ, Gurevich Y, et al. Deriving 
ICD-10 Codes for Patient Safety Indicators for Large-scale Surveillance Using 
Administrative Hospital Data. Med Care. 2017;55(3):252–60.  
 
 
 

 
 
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Appendix A. Standard of care monitoring by unit and clinical situation at St. Paul’s Hospital 
Unit 
Clinical Situation 
Monitoring Guidelines 
PACU 
  
If unconscious 
Arterial BP (if needed), HR and SpO2: automatically 
collected continuously 
Noninvasive BP: q5min 
T, RR, POSS and Pain: q5min until awake or POSS of 3 or 
less 
Nursing: patient ratio 1:1 
If awake 
Arterial BP (if needed), HR and SpO2: automatically 
collected continuously 
Noninvasive BP: q5min 
T, RR, POSS and Pain: q15 min x 8 then q 30 min x 4, then q 
1h until discharge from phase 1 or PACU 
Nursing: patient ratio 1:2 
SHAU 
 All patients  
Arterial BP (if needed): automatically collected continuously 
Noninvasive BP, RR, HR and SpO2: q30min x 4 then q1h, 
may be done more frequently depending on the clinical 
situation  
T and Pain: q1h until discharge from SHAU 
Nursing: patient ratio 1:1 if unconscious, 1:2 if awake 
Patients on the 
Obstructive Sleep 
Apnea protocol 
End-tidal Carbon Dioxide and SpO2: continuously 
Wards, 
PACU, 
or 
SHAU 
  
 All patients  
Vital Signs: q4h x 48 hours, then q8h x 48hours, then BID 
until discharge or as ordered by physician or nurse practitioner  
Ketamine Infusion Vital Signs: q1h X 4 hours, then q4h for duration of infusion 
Lidocaine Infusion 
BP, HR, T, RR, and SpO2: q15 min x 1 hour, then q1h x 4 
hours, then q4h and PRN for duration of infusion 
POSS: q15 min x 1 hour, then q 1h x 4 hours, then q2h and 
PRN for duration of infusion 
Pain: q15 min x 1 hour, then q1h x 4 hours, then q2h and PRN 
for duration of infusion 
Patient Controlled 
Analgesia (PCA) 
POSS, RR, and Pain: q15 min x 30 min, then q1h x 4 hours, 
then q2h x 24 hours, then q 4h for duration of therapy 
SpO2, BP and HR: q 15 min x 30 min, then q 1h x 4 hours, 
then q 4h for duration of therapy 
Epidural Analgesia 
BP and HR: q 15 min x 4, then q 30 min x 1 hour, then q 4h 
(start in PACU) & PRN 
Postural BP and HR: Prior to first ambulation 
RR, SpO2, Pain, and POSS: q 1h x 12 hours, then q 2h x 12 
hours, then q 4h & PRN 
Abbreviations: blood pressure (BP), heart rate (HR), temperature (T), respiratory rate (RR), oxygen 
saturation (SpO2), Pasero Opioid Sedation Scale (POSS), and pain assessment (Pain) 

 
 
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Appendix B. Study device logistics  
Task  
In-hospital monitoring  
At home monitoring 
Teaching patient 
and caregiver how 
to use the device  
After consent and prior to the 
surgery preferably, may teach within 
24h postoperatively if needed  
Prior to discharge. Patients will be 
assigned a username and password for 
using the device 
Device initiation  
By study personnel 
By patient or caregiver, once at home. 
Study personnel may provide guidance 
through Telehealth.  
Device 
troubleshooting 
and servicing  
Study personnel will review in-
person, and contact Medtronic if 
needed  
 
Cloud DX Support Line for patient to call 
directly (may also call study personnel)   
Cloud DX Support: 
Tel:1-888-543-0944 
Email: support@clouddx.com 
Hours (PT): Monday-Friday 5:30am-
5:00pm; Weekend & Holidays 6:00am-
2:00pm 
Device charging 
and/or battery 
change  
By patient or caregiver, with 
guidance from study personnel. Will 
be provided with spare batteries 
where needed. 
By patient or caregiver, once at home. 
Study personnel may provide guidance 
through Telehealth. Will be provided with 
spare batteries where needed. 
Device removal  
By patient or caregiver (e.g. 
physiotherapy, shower) with 
guidance from study personnel. By 
study personnel prior to discharge if 
required.  
By patient at home  
Device return and 
collection  
Study personnel (device may be left 
in the ward if the study personnel 
cannot get to the patient in time or 
during evenings/weekends).  
Prepaid shipping label and box provided 
to the patient and caregiver    
Device cleaning 
and removal of 
data from previous 
patient  
Study personnel 
Study personnel (once received device 
back in hospital), using Cavi wipes or 
70% alcohol wipes. Data from previous 
patient will be removed on the devices, 
which removes any saved login 
information to the Connected Health app, 
i.e., access to app and any data within the 
app.  
 
 
 

 
 
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Appendix C. Study devices Components 
Device Name 
Device 
Components 
Description 
Power Supply 
Location of 
Usage 
Medtronic 
Philips 
Intellivue 450 
One piece 
monitor 
A portable monitor 
with multi-
measurement module 
Plug-in 
In hospital 
Cloud DX 
Health Kit 
Blood pressure 
monitor 
A non-invasive, 
wireless device 
intended for spot-
checking of blood 
pressure and pulse 
rate in the home 
healthcare 
environment 
4 AA batteries 
At home 
Thermometer 
A digital infrared 
device intended for 
spot-checking of 
body temperature 
1 button cell 
battery 
Pulse oximeter  
A non-invasive 
device intended for 
spot-checking of 
oxygen saturation of 
arterial hemoglobin 
(SpO2) and pulse rate 
2 AAA batteries 
Android tablet 
A pre-programmed 
cellular tablet with a 
data plan to support 
all the companion 
Apps, 
communications and 
data transfer. 
Rechargeable 
Lithium-Ion 
battery 
 
 
 

 
 
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Appendix D. Definitions of Outcomes 
 
vii Myles PS, Shulman MA, Heritier S, Wallace S, McIlroy DR, McCluskey S, Sillar I, Forbes A. Validation of days at 
home as an outcome measure after surgery: a prospective cohort study in Australia. BMJ Open. 
2017;7:e015828. 
viii McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, et al. Post-discharge after surgery Virtual Care 
with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled 
trial. BMJ. 2021 Sep 30;374:n2209. 
ix The Vascular events In non-cardiac Surgery patIents cOhort evaluatioN (VISION) Study Investigators. 
Association between complications and death within 30 days after noncardiac surgery. 
CMAJ Jul 2019, 191 (30) E830-E837; DOI: 10.1503/cmaj.190221 
Name of Outcomes 
Definition 
Days alive and at home 
within 30 days (DAH30) 
vii viii 
Number of days within 30 days of surgery when participant is alive and at 
home, without visiting an emergency department or urgent care centre or 
being admitted to a hospital. Home refers to their own home, or a residence 
of a relative, friend or acquaintance, but excludes a nursing home or a 
rehabilitation facility.  
Participants lose days alive at home if they: go to an emergency department 
or urgent-care centre; become inpatients at a hospital; or die.  
If a participant visits an emergency department or urgent care centre, or is 
admitted to a hospital any time between midnight and 23:59 on a given day, 
they will lose that day as a day alive at home. If they remain in the care 
facility past midnight into the next day, then they lose 2 days alive at home. 
They will continue to lose days alive at home until the day in which they are 
home from midnight for an entire day. In other words, a day alive at home 
can be counted only when participants spend an entire day from midnight to 
23:59 at home, without being stay at an emergency department, an urgent-
care centre or a hospital.  
DAH30 will be counted within 30 days after surgery, with the day of 
surgery as day 0.  
Major bleedingix 
Within 30 days postoperatively. The diagnosis of major bleeding requires 
that the bleeding has resulted in a drop in hemoglobin to <70 g/L, 
transfusion of ≥1 unit of packed red blood cells, or death. 
Myocardial injury after 
non-cardiac surgery 
(MINS)Error! 
Bookmark not defined. 
Within 30 days postoperatively. MINS will be measured by Troponin T 
(hsTnT) assay. The diagnostic criteria for MINS are an elevated 
postoperative hsTnT (20 to <65 ng/L with an absolute change ≥5 ng/L or an 
hsTnT ≥65ng/L) judged as resulting from myocardial ischemia, without the 
requirement of an ischemic feature. 
SepsisError! Bookmark 
not defined. 
Within 30 days postoperatively. Sepsis is defined by the presence of both 
infection and a systemic inflammatory response. Systemic inflammatory 
response requires ≥2 of the following factors: core temperature >38º C or 
<36º C; heart rate >90 beats per minute; respiratory rate >20 breaths per 
minute; white blood cell count >12 x 109/L or <4 x 109/L. 
Infection without 
sepsisError! Bookmark 
not defined. 
Within 30 days postoperatively. Infection is defined as a pathologic process 
caused by the invasion of normally sterile tissue or fluid or body cavity by 
pathogenic or potentially pathogenic organisms. Infection without sepsis 
has to fulfill the definition of infection without fulfilling the definition of 
sepsis. 

 
 
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x Borges FK, Nenshi R, Devereaux PJ. Fast track pathway to accelerated cholecystectomy versus standard of care for 
acute cholecustitis (FAST) Pilot trial protocol. Forthcoming 2021. 
xi Kleif J, Waage J, Christensen KB, Gögenur I. Systematic review of the QoR-15 score, a patient- reported outcome 
measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. 
doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. 
Acute kidney injury with 
new dialysisError! 
Bookmark not defined. 
Within 30 days postoperatively. It is defined as an acute kidney injury that 
resulted in new dialysis 
Strokex 
Within 30 days postoperatively. Stroke is defined as either: 1) a new focal 
neurological deficit thought to be vascular in origin with signs or symptoms 
lasting ≥24 hours or leading to death; or 2) a new focal neurological deficit 
thought to be vascular in origin with signs or symptoms lasting <24 hours 
with positive neuroimaging consistent with a stroke. 
Venous 
thromboembolismError! 
Bookmark not defined. 
Within 30 days postoperatively.  Venous thromboembolism was a 
composite of deep venous thrombosis and pulmonary embolism. 
Deep venous thrombosis of the leg or arm is defined as having any one of 
the following: 1) a persistent intraluminal filling defect on contrast 
venography; 2) non-compressibility of one or more venous segments on B 
mode compression ultrasonography; or 3) a clearly defined intraluminal 
filling defect on contrast enhanced CT. 
Pulmonary embolus is defined as having any one of the following: 1) a high 
probability ventilation/perfusion lung scan; 2) an intraluminal filling defect 
of a segmental or larger artery on a helical computed tomography(CT) scan; 
3) an intraluminal filling defect on pulmonary angiography; or 4) a positive 
diagnostic test for deep venous thrombosis (e.g., positive compression 
ultrasound) and one of the following - non-diagnostic (i.e., low or 
intermediate probability) ventilation/perfusion lung scan, or a non-
diagnostic (i.e., subsegmental defects or technically inadequate study) 
helical CT scan. 
Congestive heart 
failureError! Bookmark 
not defined. 
The definition of congestive heart failure required at least one of the 
following clinical signs - an elevated jugular venous pressure, respiratory 
rales/crackles,  crepitations, or presence of S3, with at least one of the 
following radiographic findings - vascular redistribution, interstitial 
pulmonary edema, or frank alveolar pulmonary edema. 
Death 
All cause mortality within 30 days of surgery 
Emergency department 
visit 
Participant visit to an emergency department after discharge within 30 days 
of surgery 
Hospital readmission 
Participant readmission to a hospital after discharge within 30 days of 
surgery 
Urgent care centre visit 
Participant visit to an urgent care centre after discharge within 30 days of 
surgery 
Family doctor clinic visit 
Participant visit to a family doctor clinic after discharge within 30 days of 
surgery 
Postoperative length of 
stay 
The time from the date of the surgery to the date of discharge from the 
hospital 
Quality of recovery 
(QoR-15)xi 
Measured preoperatively and at 14 and 30 days postoperatively. QoR-15 is 
a 15 item patient-reported outcome measurement that measures quality of 
recovery after surgery and anesthesia. It has been validated by multiple 
clinical trials and found to have good content validity, good internal 
consistency and essential unidimensionality.  

 
 
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xii Royal College of Physicians . National Early Warning Score (NEWS) 2: Standardising the assessment of acute-
illness severity in the NHS. RCP, 2017. 
xiii Brooke J. SUS: a quick and dirty usability scale. ResearchGate. 1995. Nov, [2021-11-21]. 
https://www.researchgate.net/publication/228593520_SUS_A_quick_and_dirty_usability_scale. 
xiv Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital 
Health Apps: Meta-analysis. JMIR Mhealth Uhealth 2022;10(8):e37290. URL: 
https://mhealth.jmir.org/2022/8/e37290. DOI: 10.2196/37290 
Vital sign derangementxii 
Detected during the enhanced continuous monitoring period. It is defined as 
a vital sign value exceeds the following thresholds: 
Systolic BP <=100, or >=220 mmHg 
SpO2 <=93% for non-COPD patients; or <=87%, or >=93% on oxygen for 
COPD patients 
HR <=50 or >=91 beats per minutes 
Temperature <=36.0ºC  or >=38.1ºC 
The extent, frequency and clinical impact of the derangement as well as the 
derangements that are missed by standard of care monitoring will be 
recorded.  
Escalation of care 
See the “Definitions of escalation types” in the protocol. The escalated care 
required, and time between vital sign alert and care escalation will be 
documented during the enhanced continuous monitoring period.  
Patient experience of 
device use 
During the enhanced continuous monitoring, participants in the intervention 
group will be asked to record the frequency, duration and problem 
encountered when using the continuous vitals monitors. The reasons that 
participants took the monitors on and off, any adverse events, and to what 
extent the monitors may have affect their daily life will also be recorded.  
System Usability Scale 
(SUS)xiii xiv 
Measured at 4 days postoperatively (for Phillips) and 4 days post-discharge 
(for Cloud Dx). SUS is a patient-reported measurement which includes ten 
5-point rating scales of usability of a system. The suitability of using SUS 
for evaluating medical devices has been well established.   
Technical support 
required 
Technical issues encountered and the technical support needed during the 
enhanced continuous monitoring period.   
 
 

 
 
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Appendix E: Study variables and data sources 
Outcome 
Variable 
Group  
Data source 
Patient 
characteristics 
Demographics:  
Age at surgery 
Gender 
Ethnicity 
Education 
BMI 
Both  
Enrollment 
questionnaire & 
Cerner & Chart review 
 
Health condition before 
surgery:  
Smoking 
Chronic pain 
Obstructive sleeping apnea 
Myocardial infarction 
Atrial fibrillation 
Congestive heart failure 
Transient ischemic attack 
COPD 
Peripheral arterial disease 
Stroke 
Deep vein thrombosis 
Pulmonary embolism 
Diabetes 
Cancer 
Need assistance with activities 
of daily living 
Charlson comorbidity index 
ASA 
RCRI 
CVA 
Both  
Chart review & Cerner 
 
Surgery information: 
Date of surgery 
Surgery type 
Urgency of surgery 
Anesthesia 
Procedure 
End of surgery 
Postoperative disposition 
Both  
Cerner & Chart review 
Trial Outcomes 
 
 
 
Primary trial outcome DAH30 
Both  
Cerner 
Secondary trial 
outcomes 
Morbidity (within 30 days 
postoperatively): 
Major bleeding 
Myocardial infarction after 
non-cardiac surgery 
Acute myocardial infarction 
Both  
Chart review 

 
 
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Sepsis 
Infection without sepsis 
Acute kidney injury with new 
dialysis 
Stroke 
Venous thromboembolism 
Congestive heart failure 
 
Mortality (within 30 days 
postoperatively) 
Both  
Cerner 
 
Health care utilization within 
30 days postoperatively:  
Emergency 
Hospital 
Urgent walk-in clinic 
Family doctor clinic 
Both  
Chart review & Phone 
call follow up 
 
Postoperative length of stay 
Both  
Cerner & Chart review 
 
Quality of recovery (QoR-15) – 
before surgery 
Both  
QoR-15 questionnaire 
 
Quality of recovery (QoR-15) – 
before surgery 
Both  
QoR-15 questionnaire 
 
Quality of recovery (QoR-15) – 
before surgery 
Both  
QoR-15 questionnaire 
 
Vital sign derangements 
(extent, frequency, clinical 
impact) detected through 
continuous vitals monitoring:  
In hospital, that were missed by 
standard monitoring 
At home 
Intervention 
group 
Chart review & 
CareFlow & Research 
tracking files 
 
Care escalation required as a 
result of the additional data 
from enhanced monitoring: 
In hospital 
At home 
Intervention 
group 
Chart review & 
CareFlow & Research 
tracking files 
Feasibility Outcomes  
 
 
Participation 
measures 
# of patients meeting the 
clinical inclusion criteria 
Both  
Research tracking files 
 
# of patients excluded and the 
reasons, based on the exclusion 
criteria 
Both  
Research tracking files 
 
# of patients approached for 
recruitment 
Both  
Research tracking files 
 
# of patients provide consent 
Both  
Research tracking files 
 
# of patients withdrawal 
Both  
Research tracking files 
Accessibility  
Participant use of the devices 
Intervention 
group 
Daily log sheet 

 
 
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Reasons for taking the device 
on and off 
Intervention 
group 
Daily log sheet 
 
Instances of interruption in 
monitoring > 4 hours 
Intervention 
group 
Daily log sheet 
 
Participant evaluation of the 
enhanced monitoring 
Intervention 
group 
Daily log sheet & 
System Usability Scale 
(SUS) 
Clinical Resource 
Utilization 
Frequency and type of vital 
sign derangements detected by 
enhanced monitoring and the 
resulting care escalation 
Intervention 
group 
Hospital charts & 
Cerner & Research 
tracking files 
 
Time between vital sign alert 
and care escalation 
Intervention 
group 
Hospital charts & 
Cerner & Research 
tracking files  
 
Logistics of device use (time 
spent on education, initiation, 
troubleshooting etc.) 
Intervention 
group 
Research tracking files 
 
Issues that arise in the 
workflow 
Intervention 
group 
Research tracking files 
Evaluation of 
potential harm or 
safety issues 
Any participant-reported 
adverse events  
Intervention 
group 
Research tracking files 
& Daily log sheet 
 
Mobility affected by enhanced 
monitoring 
Intervention 
group 
Daily log sheet 
 
Daily activity affected by 
enhanced monitoring 
Intervention 
group 
Daily log sheet 
 
Anxiety caused by enhanced 
monitoring 
Intervention 
group 
Daily log sheet 
Cost analysis 
Staffing required for 
recruitment and consenting 
Overall 
sample 
Research tracking files 
 
Costs related to randomization 
Overall 
sample 
Research tracking files 
 
Honorarium for participants 
Overall 
sample 
Research tracking files 
 
Research staff costs compared 
to standard of care monitoring 
Intervention 
group 
Research tracking files 
 
Costs related to device 
collection  
Intervention 
group 
Research tracking files 
Logistics of the 
Study questionnaires 
Completion rates 
Both  
Research tracking 
sheet 
 
Method of completing the 
questionnaires 
Both  
Research tracking 
sheet 
 
Support needed in completion 
of questionnaires 
Both  
Research tracking 
sheet