Engineering Evaluation of the Helix Ventilator
Phase: NA
Conditions: Respiratory Disease, Pulmonary Disease, Pediatric ALL
Sponsor: Philips Respironics

            
 
 
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Protocol Title: 
Engineering Evaluation of the Helix Ventilator 
 
Protocol Number: 
HRC-17067-HCPED-CC 
 
Revision: 
Rev 2.0 
 
Investigators: 
Allen J. Dozor, MD 
Sankaran Krishnan, MD, MPH 
Phone: 1-914-493-7585 
 
 
 
 
 
 
 
 
 
 
 
Site: 
 
 
 
Pediatric Pulmonology, Allergy & Sleep Medicine 
New York Medical College 
40 Sunshine Cottage Road - Skyline 1N-D30 
Valhalla, NY 10595 
 
 
 
Sponsor: 
 
 
Respironics, Inc. a Philips Company (“Philips Respironics”) 
1740 Golden Mile Highway 
Monroeville, Pa 15146 
1-(724)-733-0200 
http://www.respironics.com/ 
 
 
 
 
Confidential 
 
This protocol, its contents and the information relating to it are the proprietary property of Philips 
Respironics. All information is to be kept confidential. 
 
 
 
 
 

            
 
 
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Protocol Approval 
 
 
Investigator Statement 
 
As Investigator of the study titled Engineering Evaluation of the Helix Ventilator , I agree to:  
 
(i) conduct the Study in accordance with: this Investigator Agreement; the Study’s Protocol as approved 
by the IRB (the “Protocol”); all applicable laws and regulations; Good Clinical Practice and the 
Declaration of Helsinki;  and any IRB or FDA conditions of approval;   
(ii) await IRB approval for the Protocol before obtaining informed consents; 
(iii) ensure that all requirements for informed consent are met and not let any subject participate in the 
Study before obtaining that subject’s informed consent;  
(iv) not make modifications to the Protocol as supplied to me by Respironics, Inc. (the “Sponsor”), 
without first obtaining the written approval of the Sponsor;  
(v) provide the Sponsor with accurate financial information as required by appropriate regulations; 
(vi) supervise all testing of investigational devices that involves any Study subject;  
(vii) maintain Study documentation for the period of time as required by appropriate regulations; and 
(viii) supply to the Sponsor, as part of this Investigator Agreement, my curriculum vitae. 
 
 
INVESTIGATOR 
 
 
 
 
 
 
Signature: 
_________________________________________________ 
 
Printed Name: _________________________________________________ 
 
 
 
Date:  
____________________ 
 
 
 
 
 

            
 
 
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TABLE OF CONTENT 
 
GLOSSARY OF DEFINITIONS AND TERMS ............................................................ 4 
DOCUMENT CONTROL PAGE .................................................................................... 6 
PROTOCOL REVISIONS ............................................................................................... 7 
TARGET PATIENT POPULATION ........................................................................... 10 
II. STUDY OBJECTIVE: ............................................................................................... 10 
III. SUBJECT SELECTION .......................................................................................... 11 
IV. SUBJECT ENROLLMENT .................................................................................... 12 
V. STUDY PROCEDURES ............................................................................................ 12 
VI. STATISTICAL ANALYSIS .................................................................................... 13 
VII. RISKS AND DISCOMFORTS .............................................................................. 13 
VIII. POTENTIAL BENEFITS ..................................................................................... 13 
IX. MONITORING AND QUALITY ASSURANCE .................................................. 14 
X. REFERENCES ........................................................................................................... 15 
 
 
 
 
 

            
 
 
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Glossary of Definitions and Terms 
 
Active with Flow Circuit Type: A single limb circuit with an active exhalation valve and proximal flow 
sensor.   
 
Active with Proximal Flow Circuit Type: A single limb circuit with an active exhalation valve with 
proximal pressure.  
 
BI-Flex: A comfort feature of a Bi-Level PAP device that provides additional pressure relief during the 
later stage of the inspiration and during active exhalation. 
 
CPAP Pressure: pressure needed to maintain an open airway in a sleep apnea patient treated with CPAP, 
expressed in centimeters of water (cm H20). The positive pressure can range from 4 - 25 cm H20. 
Different patients require different pressures. The value is determined in a CPAP titration study.  
 
CPAP Therapy: Continuous Positive Airway Pressure – delivers a constant pressure during inspiration 
and expiration. 
 
Dual Limb Circuit Type:  A dual limb circuit with an active exhalation valve and proximal flow sensor. 
 
EPAP: Expiratory Positive Airway Pressure-Physician prescribed pressure for the expiratory (breathing 
out) phase of an individual on Bi-level PAP therapy  
 
Hypersomnolence: Excessive daytime sleepiness. 
 
IPAP: Inspiratory Positive Airway Pressure - Physician prescribed pressure for the inspiratory (breathing 
in) phase of an individual on Bi-level PAP therapy. 
 
Mode of Ventilation:  represents a combination of control, phase and conditional variables that establish 
a set pattern of spontaneous and/or mandatory breaths. 
 
Noninvasive Positive Pressure Ventilation (NPPV):  mechanical ventilation provided noninvasively (by 
mask or similar interface) rather than through an endotracheal tube or tracheostomy. 
 
Passive Circuit Type: A single-limb circuit with an exhalation port. 
 

            
 
 
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Positive End-Expiratory Pressure (PEEP):  addition of positive airway pressure during the exhalation 
phase. 
 
Pressure Control Ventilation:  mode of ventilation in which airway pressure is set and remains constant 
with changes in resistance and compliance; may prevent localized alveolar over distention with changes in 
resistance and compliance. 
 
Spontaneous Breath:  inspiration that is patient triggered and patient cycled. 
 
Volume Control Ventilation:  mode of ventilation in which the ventilator controls the inspiratory flow 
and tidal volume is determined by the flow and the inspiratory time; in practice, the tidal volume in this 
mode is delivered regardless of resistance or compliance. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

            
 
 
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DOCUMENT CONTROL PAGE 
 
Study Name 
Engineering Evaluation of the Helix Ventilator 
 
Protocol Number   
HRC-17067-HCPED-CC  
 
Protocol Version 
2.0 
 
Version Date 
 October 26th, 2018 
 
Author(s) 
Chuck Cain, Manager Clinical Research 
 
Sponsor 
Respironics, Inc. a Philips Company (“Philips Respironics”)1740 Golden Mile Highway 
Monroeville, PA 15146 
1-(724)-733-0200 
http://www.respironics.com/ 
 
Study Monitor(s) 
Chuck Cain          
 
 
 
 
Jonathan Hughes                                                                 
Manager, Clinical Research                                       Sr. Clinical Research Associate                       
Philips Respironics                                                     Philips Respironics       
1010 Murry Ridge Lane 
 
 
 
1010 Murry Ridge Lane       
Murrysville, PA 15668 
 
 
 
Murrysville, PA 15668        
Tel:  724-733-5835                                                     Tel : 724-387-5273                                                                         
E-mail: Chuck.Cain@philips.com 
 
 
Email: Jonathan.Hughes@philips.com                                          
     
 

            
 
 
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PHILIPS RESPIRONICS, INC.  CONTACT INFORMATION 
 
 
 
 
Reporting of Adverse Events or Adverse Device Effects 
Report the occurrence of an adverse event or adverse device effect to Philips Respironics within 24 hours 
of the occurrence. 
 
Chuck Cain          
 
 
 
 
Jonathan Hughes                                                                 
Manager, Clinical Research                                       Sr. Clinical Research Associate                       
Philips Respironics                                                     Philips Respironics       
1010 Murry Ridge Lane 
 
 
 
1010 Murry Ridge Lane       
Murrysville, PA 15668 
 
 
 
Murrysville, PA 15668        
Tel:  724-733-5835                                                     Tel : 724-387-5273                                                                        
E-mail:chuck.cain@philips.com 
 
 
Email : Jonathan.Hughes@philips.com                                         
 
 
 

            
 
 
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PROTOCOL REVISIONS 
 
Rev 
Level 
 
Changes Made for  
 
Date 
 
Contributors 
0.0 
 Original Release 
05/26/2017 
C. Cain, M.McDermott, 
C.Vogler 
1.0 
Protocol updated per IRB comments 
- 
Updated primary objective 
- 
Change in inclusion criteria from age 
to weight class >5Kg 
- 
Clarification on study staff roles 
during testing 
- 
Other administrative language changes 
 
09/21/17 
C. Cain 
2.0 
Protocol updated to reflect registration on 
clinicaltrials.gov 
 
10/26/2018 
J. Hughes, C. Cain,  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

            
 
 
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I. Background and Significance 
 
History of Ventilators 
 
A ventilator’s main purpose is to assist or replace the patient’s respiratory muscles in performing the work 
of breathing (1).  Ventilation started during the polio epidemic in Scandinavia and the United States. 
Negative pressure ventilators such as the Iron Lung, were the most commonly used mechanical ventilators 
throughout the 1950’s. After control of the Polio epidemic, invasive positive pressure ventilation via 
endotracheal tube or tracheostomy was predominant over non-invasive ventilation, largely because of its 
reliability and provision of direct access to the airway. Invasive positive pressure ventilation means that 
positive pressure is applied to the patient’s airway through an endotracheal or tracheostomy tube and 
causes gas to flow into the lungs until the ventilator breath is terminated.  As the airway pressure drops to 
zero, the elastic recoil of the chest pushes the tidal volume out, accomplishing passive exhalation (2).   
The major difference between invasive and noninvasive ventilation is that with noninvasive ventilation, 
gas is delivered to the airway via a mask or “interface” rather than via an invasive conduit (endotracheal 
or tracheostomy tube) (3). With noninvasive ventilation, the positive pressure to the patient is partially or 
fully provided by the ventilator. 
 
Noninvasive Ventilation  
 
Types of diseases that have been successfully treated with noninvasive ventilation include, but are not 
limited to, obstructive lung diseases (chronic obstructive pulmonary disease (COPD), asthma, cystic 
fibrosis, upper airway obstruction), restrictive lung diseases (chest wall deformity, neuromuscular 
diseases, obesity hypoventilation), parenchymal lung disease (AIDS-related pneumonia, acute respiratory 
distress syndromes (ARDS), infectious pneumonia) and cardiogenic (acute pulmonary edema) (3). 
Patients with these types of diseases may develop chronic derangement of daytime gas exchange yielding 
daytime hypoxia and hypercapnia. Such patients are said to have chronic respiratory insufficiency. 
Patients with chronic respiratory insufficiency fail to achieve adequate ventilation and gas exchange, 
especially during sleep and such ineffective breathing disrupts nocturnal sleep and manifests as daytime 
sleepiness (hypersomnia), early morning headache (due to hypercapnia), dyspnea, fatigue and cognitive 
dysfunction.  Pulmonary hypertension and right heart failure can develop as well.  Correction of such 
ventilatory and gas exchange abnormalities using noninvasive positive pressure ventilation (NPPV) is an 
increasingly popular method for improving sleep quality, heath-related quality of life, functional status 
(cognitive and physical), and daytime gas exchange.  In addition, the use of nocturnal NPPV has been 
associated with an improvement in quality of life and overall survival in certain patient populations, such 
as Amyotrophic lateral sclerosis (ALS). 
 
NPPV is often used for patients prone to respiratory muscle fatigue and respiratory failure. As the 
respiratory muscles work harder to meet the need for oxygen, they tire and become less efficient. That in 

            
 
 
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turn causes O2 to drop and CO2 to rise, eventually precipitating respiratory acidosis. Respiratory acidosis 
only further impairs respiratory muscle activity and increases the drive to breathe in an already exhausted 
patient. The system is able to adequately support the ventilation and oxygen needs of patients who are 
able to breathe spontaneously but whose efforts are unable to meet their total respiratory requirements.  
 
Invasive Ventilation 
 
Many of the disease states listed above for noninvasive ventilation are progressively declining disease 
states that may ultimately lead to the need for invasive ventilation.    Invasive ventilation is indicated 
when the patient’s spontaneous ventilation and non-invasive ventilation are not adequate to sustain life.  
Some common indications for employing invasive ventilation include, but are not limited to (2): 
• Apnea with respiratory arrest 
• Acute lung injury 
• Chronic obstructive pulmonary disease (COPD) 
• Chronic restrictive pulmonary disease 
• Neuromuscular Disease 
 
Many of these disease states will require invasive ventilation in the home.   Invasive ventilators used in 
the home setting aid in augmenting or replacing spontaneous ventilatory efforts to achieve medical 
stability in a non-acute setting. This capability allows the tracheotomized patient to return home and still 
receive adequate ventilatory support (4). 
 
The goals of home invasive mechanical ventilation (via tracheostomy) are to sustain and extend life, to 
enhance the quality of life, to reduce morbidity, to improve or sustain physical and psychological function 
and to provide cost effective care (4). 
 
The device that will be used in this study is intended to supply the support that is needed for all phases of 
the patient’s disease from noninvasive to invasive ventilation. 
 
Study Device  (Helix Ventilator) 
 
The Helix ventilator is a non-FDA cleared ventilator device. Helix is the next generation Trilogy 
ventilator platform. The Helix ventilator has similar modalities to the Trilogy ventilator, which has FDA 
clearance.  The Helix device has improved algorithms, controls, and features to enhance the therapy 
delivery.  Additionally, Helix has an updated hardware platform which has been adequately tested to 
ensure that the device specifications are met. No pre-clinical or developmental clinical work was required 
because of Trilogy being the established predicate.  
The Helix ventilator provides invasive and non-invasive positive pressure ventilation for the care of 
patients ≥2.5 kg through adults. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, 

            
 
 
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Respiratory Rate, and Heart Rate data when integrated with the appropriate accessories.  The ventilator is 
suitable for use in institutional, home, and transport settings  
The Helix ventilator is a medical device intended for use by qualified, trained personnel under the 
direction of a physician according to its technical specifications. 
The Helix ventilator delivers pressure or volume ventilation through a controlled leak valve or a passive 
exhalation port.  The Helix system accepts data from external sensors (pulse oximetry, capnography) and 
provides monitoring capability with or without ventilation.  
 
 
 
 

            
 
 
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Therapy Modes for Helix Ventilator  
 
The device that is being evaluated in this study can provide many different modes of therapy in both 
pressure support and volume controlled ventilation. 
 
The following is a list of modes that may be provided with these devices, dependent on patient 
prescriptions: 
• Continuous Positive Airway Pressure (CPAP) with optional C-Flex 
• Spontaneous Pressure Support (S) with optional Bi-Flex 
• Spontaneous/Timed Pressure Support (S/T) 
• Pressure Control Pressure Support (PC) 
• Timed Pressure Support (T) 
• Averaged Volume Assured Pressure Support (AVAPS) in conjunction with the modes listed above 
(S, S/T, PC, T) 
• Volume Control Ventilation (CV) 
• Volume Assist Control (AC) 
• Synchronous Intermittent Mandatory  Ventilation (SIMV) 
• Pressure Control SIMV (PC SIMV) 
• Pressure Regulated Volume Control (PRVC) 
 
 
Target Patient Population 
 
The patient population is extremely varied. The patient’s age will vary from infant (≥ 5kg) to adult.  The 
medical condition of the patient population ranges from critically ill acute respiratory conditions to pre-
existing or developing chronic conditions.  Patients treated with the Helix ventilator may suffer from 
diseases or injuries requiring invasive or non-invasive ventilation.  Many of these diseases result in 
respiratory failure, which can be classified as acute or chronic.  Acute respiratory failure is typically 
treated in a hospital ICU or sub-acute hospital, while chronic respiratory failure is treated at home or in a 
long term care facility.  Specific examples of respiratory failure include, but are not limited to: 
- 
Neuromuscular diseases leading to respiratory failure: Amyotrophic Lateral Sclerosis (ALS), 
Spinal Muscular Atrophy (SMA), Duchenne Muscular Dystrophy (DMD) 

            
 
 
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- 
Chronic Obstructive Pulmonary Disease (COPD) 
- 
Asthma 
- 
Spinal cord injuries 
- 
Thoracic cage deformities 
- 
Pneumonia originating from infectious disease such as influenza 
- 
Pulmonary edema (symptom of congestive heart failure) 
- 
Trauma leading to Acute Lung Injury (ALI) 
- 
Acute Respiratory Distress Syndrome (ARDS) 
 
 
II. Study Objective  
 
The objective of this Engineering study is to verify the overall performance and controls of the Helix 
Ventilator.  
 
 
Specific Aims 
1. To collect and compare pressure and flow data between the participant’s current therapy device 
and the Helix ventilator in either invasive or non-invasive ventilation. Pressure and flow 
waveform data will be evaluated to assess ventilator performance such as delivered pressure such 
as volume control accuracy, patient synchrony (triggering/cycling), and measured/calculated 
parameter accuracy.  
2. To evaluate the therapy delivery using alternate circuit types, such as mouthpiece ventilation 
(MPV) or passive dual limb 
3. To obtain participant feedback regarding the comfort of the therapy delivery. 
4. To obtain caregiver feedback related to the usability of the study device 
5. To evaluate the alarm functionality of the study device. 
6. To compare the device’s Spirometry measurement while it is operating on standard and alternative 
circuits, (Tidal Volume, breath rate, Peak flows) against a control measurement device 
 
 
III. Subject Selection 
 
Participants will be recruited from Boston Children’s Healthl Physician’s Group.  Initial contact will be 
made by the participant’s physician, or by his/her designee 
 
 

            
 
 
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Inclusion Criteria 
Participants  who are currently using mechanical ventilation (> 1 month at time of study participation) as 
part of medical care and have demonstrated a clinically acceptable response to this therapy and meet the 
following inclusion criteria:  
1. Weight > 5Kg; 
2. Any medical condition requiring mechanical ventilation through nasal/facial mask, mouthpiece  
or tracheostomy 
3. Any medical condition requiring mechanical ventilation for > 1 month 
 
Exclusion Criteria 
1.Participants  intubated with an endotracheal tube  
2.Clinically unstable, i.e.,  
a. Acute Respiratory Failure 
b. Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm 
Hg despite inotropic agents)  
c. Uncontrolled cardiac ischemia or arrhythmias  
d. Any participant  determined as inappropriate for the study  by the Principal Investigator 
3.Patients suffering from metastatic or terminal cancer 
4.Currently employed by a manufacturer of respiratory products or family member employed by a 
manufacturer of respiratory products 
Patient of surrogate is unable to provide informed consent 
 
IV. Study Design 
This clinical study is a non-randomized, single site, single-arm engineering clinical comparison study. 
The study is designed to collect and compare device parameters from the patient’s current ventilator 
compared to the Helix ventilator.   
 
V. Participant Enrollment 
Following initial contact by their physician or his/her surrogate, participants/surrogate will be informed 
that their participation is entirely voluntary and the decision to participate or not, will in no way affect 
their further evaluation or therapy. Subsequently, the participant or surrogate will be given a complete and 
thorough explanation of the benefits and risks or discomforts that may be anticipated with this study. 
Informed consent will be obtained prior to enrollment in the study.  
 
Sample Size: 
Up to thirty (30) participants will be recruited for this study. 

            
 
 
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VI. Study Procedures 
Following the completion of the informed consent, participants enrolled in this study will be asked to use 
their existing ventilator for up to 1 hour to collect pressure and flow data for comparison purposes against 
the Helix ventilator.   
 
Participants will then be set up on the Helix Ventilatory System using the same mode of therapy as their 
current ventilator.  Participants may receive mechanical ventilation using any patient circuit currently 
being designed for the Helix Ventilator (Passive, Active with PAP, Active with Flow, or dual limb).    
Patients currently using non-invasive ventilation may be asked to use a mouth piece in lieu of a mask 
interface. While using the study device, therapy setting may be altered by the physician or his/her 
surrogate while maintaining the ventilator needs of the patient. For e.g.,a patient currently prescribed an 
SIMV mode may temporarily be switched to a pressure control mode to assess patient synchrony and 
ventilator performance.   
 
Once the participant is set-up, he/she will be asked to use the ventilator for up to 4 hours.  During this 
time, Philips Respironics engineers will be collecting data through several mechanisms: 1)  Helix SD 
Card, 2) NICO Monitoring System, and / or 3) External data collection device (ex. laptop). The study staff 
may ask the participant’s opinions on the comfort of the therapy delivery. There will be no invasive 
monitoring as part of this study. 
 
The engineering evaluations will take place at the Boston Children’s Health Physician offices.  The study 
investigators, respiratory therapist, and/or other qualified clinical staff, will be supervising and present for 
all study visits. Philips Respironics engineers will be present for observational purposes only. All study 
staff working on this trial will be trained to the protocol and device prior to beginning work.  
 
Participants may be asked to participate in this data collection study up to six (6) times. 
 
Study data collected for this study will be collected on paper or electronic source records.  These records 
will include information regarding inclusion/exclusion, performed study procedures and questions 
regarding device use.  Only those staff that have been delegated by the Principal Investigator will be able 
to enter or make changes to the data in the Case Report Forms.  

            
 
 
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VII. Statistical Analysis 
The purpose of this Engineering study is to collect engineering and subjective data on the Helix 
Ventilatory System and the patient’s existing ventilator device for comparison purposes.  Therefore, no 
formal analysis of the data is planned. 
 
 
Determination of Sample Size 
Up to 30 participants will be enrolled in the study.  Since this is an engineering study to address issues 
which arise, no sample-size calculation was performed. 
 
General Considerations 
The primary analysis will be performed including all completed participants.  Descriptive data tables will 
be provided for all variables of interest.  Continuous data will be presented by mean, standard deviation, 
median, minimum, and maximum observation.  Data will be presented in the untransformed and 
transformed format (if applicable) for each continuous variable.  Categorical data will be presented as 
frequencies and percentages.  All analyses will be conducted using either SAS® or SPSS® software. 
 
Participant Disposition 
Participant disposition, including the total number of participant’s enrolled, completed, early terminations 
and withdrawals, will be presented overall and by software version. A listing will be provided with the 
reasons for discontinuation.  
 
Demographics and Baseline Characteristics 
 
Standard subject demographics (e.g., age and gender) and baseline characteristics will be summarized for 
all participants enrolled and for evaluable participants. 
 
Trends Analysis 
The aim of this Engineering study is to verify the performance and controls of the Helix Ventilator.  If 
formal significance testing is required, the endpoints will be compared between the device versions, 
including device hardware, software,  
 
For continuous data, within-subject comparisons between two iterations will be performed using paired t-
tests or the non-parametric Wilcoxon Signed-Ranks test, depending on the distribution of the data.  
Within-subject comparisons across three or more iterations will be done using Repeated-Measures 
Analysis of Variance (RMANOVA) or the non-parametric Friedman Test.  For participants who only try 
one iteration throughout the trial, between-subjects comparisons across two iterations will be done using 
independent-samples t-tests or the Mann Whitney test. If between-subjects comparisons are made across 

            
 
 
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three or more iterations, ANOVA or the Kruskal-Wallis test will be employed.  Post-hoc pairwise 
comparisons will include an appropriate alpha adjustment. 
 
If formal analysis of categorical data is required, methods such as the Fisher’s Exact or Chi Squared Test 
will be used for between-subjects comparisons, and the McNemar Test or Cochran’s Q will be used for 
within-subject comparisons.  
 
All tests will be conducted at a significance level of p < 0.05. 
 
Treatment Compliance 
It is expected that the drop-out rate will be low as the study is an engineering trial. 
 
Safety Analysis 
Safety evaluations will be performed by recording clinical adverse events at the time originally reported, 
and they will be followed at each visit thereafter until resolution.  Adverse events will be provided in data 
listings. 
 
Interim Analysis 
There is no interim analysis planned for this study. 
VIII. Risks and Discomforts 
The risks of providing ventilatory support with the study device are no greater than the risks encountered with 
other ventilatory support devices.    
 
The devices that will be used by the subject have been tested to ensure safety. Should the device not 
perform as designed, ventilation could increase and decrease more than desired. This effect could be 
uncomfortable. Should any problems be identified, the respiratory therapist will remove the study device 
and resume ventilatory support with the participant’s current device.  
 
The Helix ventilator has similar modalities to the Trilogy ventilator, which has FDA clearance. The key 
differences between the Helix Ventilator (study device) and previously cleared Trilogy devices are that 
the Helix  device has improved algorithms, controls, and features to enhance the therapy delivery. 
Additionally Helix has an updated hardware platform which has been adequately tested to ensure that the 
device specifications are met. The improved algorithms and controls have been adequately tested to 
ensure that the delivery of therapy meets the device specifications. 
 
Respironics believes that this patient study is a low risk study that does not require an IDE because of the 
following: 
• The  predicate devices, Trilogy Family of Ventilators, have  been cleared by FDA:  

            
 
 
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o K083526 
 Trilogy 100 Ventilator 
o K093416 
 Trilogy 200 Ventilator 
o K093905 
 Trilogy 202 Ventilator 
• The study device uses existing modes of therapy, therapy features and algorithms that have been 
previously cleared by FDA 
• This patient study is recruiting stable, mechanically ventilated participants and will be conducted 
in a controlled, monitored environment 
• 
The study will be supervised at all times by a respiratory therapist and/or other qualified site clinical staff.   
 
Confidentiality:  
Participants will be instructed to contact Philips staff with any questions and concerns related to the 
device use or the study in general.  All information recorded by the study team will be study ID number.  
 
Privacy rules and requirements according to federal and state governing regulations will be implemented. 
All the information collected as part of this study will be kept confidential. All information collected for 
this study will be kept in a secured area or stored in a password protected computer if digital. 
Confidentiality of data shall be observed by all parties involved at all times throughout the clinical study.  
All data shall be secured against unauthorized access. 
The privacy of each subject and confidentiality of his/her information shall be preserved in reports and 
when publishing any data. Except when required by law, participants will not be identified by name, 
social security number, address, telephone number, or any other direct personal identifier in study records. 
For records disclosed outside the Philips Respironics, participants will be assigned a unique code number.   
 
Results of the study related data, medical history, and information obtained from the questionnaires and 
device data will be reported and received by Philips Respironics.  Philips Respironics will use participant 
study data for research purposes to support scientific and marketing objectives described in this protocol.   
 
In addition, participant records may be reviewed in order to meet federal and state regulations.  Reviewers 
may include representatives from the FDA or similar government authorities in other countries where the 
device is being used, and Philips Respironics for the purposes of the following side effects, and to gather 
additional information related to the study, and the Institutional Review Board (IRB).  Participant 
permission for review of confidential information is granted by signing the associated informed consent.  
Philips Respironics will ensure that it follows all applicable state and federal data protection regulations.  
 
 
Withdrawal Criteria: 
The term “discontinuation” refers to the participant’s premature withdrawal from the study prior to 
completing all procedures.  Participants may be discontinued from the study for any of the following 
reasons: 

            
 
 
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• 
If in the investigator’s judgement, continuation in the study may prove harmful to the participant.  
Such a decision may be precipitated by adverse events, including fever, nausea, rash, changes in vital 
signs, or the development of a new medical condition.  The investigator will be solely responsible for 
making medical/safety decisions regarding the participant’s continued participation in the study. 
• 
Noncompliance; 
• 
At the request of the participant. 
 
The study team will document whether or not each participant completed the study.  If, for any 
participant, study treatment or assessments were discontinued, the reason will be recorded. 
 
The study goal is to have 30 participants to complete throughout the study.  If a subject withdraws from 
the study, they will not be replaced.  All data collected from participants will be used in the data analysis 
unless the participant has stated they do not want their data to be used. 
 
Hard copies of the study will be kept on site for at 2 years after study completion.  The sponsor will 
maintain study records indefinitely. 
 
 
IX. Potential Benefits 
Although participation in this trial will not result in any direct benefit to the participant, they will be 
contributing to generalizable data that will help improve device design and function. The advancements 
with the Helix platform may ultimately improve patient outcomes by allowing the ventilator to provide 
better ventilation for the patient.  
 
 
X. Monitoring and Quality Assurance 
All adverse events, serious and non-serious, occurring during the course of the study will be collected, 
fully documented, and reported to the Institutional Internal Review Board by the Principal Investigator or 
study staff. Serious adverse events will be reviewed by the Sponsor within 24 hours of the study team 
being aware of the event. For each adverse event, the investigator will provide the onset, duration, 
intensity and treatment required, outcome and action taken. We anticipate that adverse events during this 
study would be minimum. Participants will only be using the therapy for 4 hours under the supervision of 
clinicians.  All reasonable care will be taken to avoid these complications. In addition to adverse event 
reporting, the investigators will report a summary of the protocol findings, participant recruitment, drop-
outs, and events to the IRB annually. 
 

            
 
 
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All device deficiencies, use or user errors, and equipment failures will be documented.  Use or User errors 
will be captured as part of the source documentation.  Device deficiencies and equipment failures will be 
kept on a separate log.  The serial numbers and type of deficiency/failure will be captured.   
 
This clinical study will be monitored by Philips Respironics Inc. (Sponsor) in compliance with the Code 
of Federal Regulations (CFR) for clinical research; namely, 21 CFR Parts 50, 54, 56 and 812 and others 
as applicable. The purpose of such monitoring is to assure that the study remains in compliance with the 
approved protocol, investigator agreement and regulatory requirements, to verify the completeness, 
reliability and accuracy of study data and to resolve any issues that arise during the conduction of the 
study. The Sponsor will scheduled monitoring visits periodically as specified by the monitoring plan that 
will be conduct by trained clinical research professionals.  A unique source record will be created for each 
study participant.  This record will include documentation of the informed consent form review process, 
HIPAA completion according to site policies, concomitant medications and applicable medical history.  
The Sponsor will have access to these source records. It has been determined that this study does not 
require a Data Safety Monitoring Board (DSMB).  
XI. Registration on ClinicalTrials.gov or other applicable registry  
This engineering study is evaluating the Helix ventilator.  It will be registered on ClinicalTrials.gov. 

            
 
 
Engineering Evaluation of the Helix Family of Ventilators 
 
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XII. References 
 
1. Hess, Dean, et al. Respiratory Care: Principles and Practices.  W. B. Saunders Company, 2002. 
 
2. Byrd, Ryland and Roy Thomas. Ventilation, Mechanical. emedicine. 2004. 
 
3. Mehta, Sangeeta and Nicholas Hill.  Noninvasive Ventilation.  Am J Respir Crit Care Med; Vol 
163: 540-577, 2001. 
 
4. AARC Clinical Practice Guidelines.  Long-Term Invasive Mechanical Ventilation in the Home.  
Respir Care; Vol 40 (12): 1313-1320, 1995.