Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase: NA
Conditions: COPD
Sponsor: Philips Clinical & Medical Affairs Global

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 1 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
 
Clinical Protocol 
 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive 
Pulmonary Disease (COPD) Patients  
 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
Written By:  
___________________________________________________________ 
Chuck Cain  
 
 
 
             
Date  
Sr. Developmental Scientist, SRC Clinical Development 
 
Approved By: 
___________________________________________________________ 
Kelli Davis 
 
 
 
 
 
 
Date  
Clinical Operations Lead, SRC Clinical Operations 
 
Approved By: 
___________________________________________________________ 
Jeff Jasko 
 
 
 
 
 
 
Date  
Senior Data Manager, Q&R Reg. & Clin. Aff. - Biostatistics/DM 
 
 
Sponsored by 
 
 
Respironics, Inc., a Philips Healthcare Company 
1740 Golden Mile Highway 
Monroeville, PA 15146 
USA 
 
 
 
 
 
 
 
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 2 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Table of Contents 
 
Document Control Page(s) .................................................................................................................... 4 
Study Sponsor: .......................................................................................................................................... 4 
Philips Respironics, Inc.  Contact Information ................................................................................ 5 
Study Monitor(s): ...................................................................................................................................... 5 
Reporting of Adverse Events or Adverse Device Effects ........................................................................... 5 
Protocol Approvals .................................................................................................................................. 6 
Protocol Revisions .................................................................................................................................. 7 
Glossary ..................................................................................................................................................... 8 
Background Information ...................................................................................................................... 10 
Description of the Intervention Studied ........................................................................................... 12 
Study Design Rationale ........................................................................................................................ 13 
Study Objectives and Purpose ........................................................................................................... 13 
Study Design: .......................................................................................................................................... 13 
Schedule of Events: ................................................................................................................................. 14 
Unscheduled Visits: ................................................................................................................................. 17 
Selection and Withdrawal of Subjects: ............................................................................................ 19 
Inclusion Criteria ..................................................................................................................................... 19 
Exclusion Criteria: ................................................................................................................................... 19 
Withdrawal: ............................................................................................................................................ 20 
Treatment of Subjects: ......................................................................................................................... 20 
Intended Use ........................................................................................................................................... 20 
Limitations/Contraindications: ............................................................................................................... 20 
Monitoring: ............................................................................................................................................. 20 
Assessment of Performance ............................................................................................................... 21 
Assessment of Safety ........................................................................................................................... 21 
Device Deficiencies ............................................................................................................................... 21 
Statistical Methods ................................................................................................................................ 21 
General Considerations ........................................................................................................................... 21 
Participant Disposition ............................................................................................................................ 22 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 3 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Safety Analysis ........................................................................................................................................ 22 
Interim Analysis ....................................................................................................................................... 22 
Direct Access to Source Data / Documents .................................................................................... 22 
Case Report Forms ................................................................................................................................ 23 
Quality Control and Quality Assurance ........................................................................................... 23 
Ethics ........................................................................................................................................................ 23 
Data Handling and Recordkeeping .................................................................................................... 24 
Financing and Insurance ..................................................................................................................... 24 
Registration on ClinicalTrials.gov or other applicable registry ................................................. 24 
Risk and Benefit Analysis .................................................................................................................... 24 
Potential Risks and Discomforts ............................................................................................................. 24 
Potential Benefits .................................................................................................................................... 25 
Compensation for Research-Related Activities ...................................................................................... 25 
Publication ............................................................................................................................................... 26 
References ............................................................................................................................................... 26 
Appendix A .............................................................................................................................................. 28 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 4 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Document Control Page(s) 
 
Protocol Title:  Engineering Evaluation of the Vector Device in Chronic Obstructive 
Pulmonary Disease patients 
 
Protocol Number: # SRC-HRC-Vector ENG -2018-10241 
 
 
 
Author(s): 
Chuck Cain  
 
 
Study Sponsor: 
Philips Respironics Inc. 
1740 Golden Mile Highway 
Monroeville, PA 15146 
724.387.7500 
 
 
Site 
Principal Investigator 
Jefferson Associates in Internal Medicine 
75 Coal Valley Road, Suite 511 
Clairton, PA 15025                                        
Michael I. Mallinger, M.D. 
412-466-6161 
Pulmonary Rehabilitation Associates 
925 Trail wood Dr,  
Youngstown, OH 44512 
Alan J. Cropp, MD 
330-758-7575 
330-502-5963 (24-hour number) 
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 5 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Philips Respironics, Inc.  Contact Information 
 
Study Monitor(s): 
 
Barbara Fink, MS, CCRP 
Senior Clinical Research Associate 
Phone: 724-708-7048 
E-mail: Barb.Fink@philips.com 
 
Kelli S. Davis, MSN, RN 
Manager, Clinical Operations 
Phone: 412-542-3621 
E-mail: Kelli.Davis@philips.com 
 
 
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. 
 
Barbara Fink, MS, CCRP 
Senior Clinical Research Associate 
Phone: 724-708-7048 
E-mail: Barb.Fink@philips.com 
 
 
 
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 6 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Protocol Approvals 
 
Investigator Agreement. 
As Investigator of the study entitled “Engineering Evaluation of the Vector NIV Device in 
Chronic Obstructive Pulmonary Disease (COPD) Patients.” Protocol # SRC-HRC-Vector 
ENG -2018-10241, 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 FDA 
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 FDA 
regulations;  
 
(viii) will supply to the Sponsor, as part of this Investigator Agreement, my curriculum 
vitae. 
 
 
 
 
Investigator Signature: 
 
 
 
 
 
 
Date:  
 
 
Printed Name: 
 
 
 
 
 
 
 
 
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 7 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Protocol Revisions 
 
Revision 
Level 
 
Changes Made to Protocol 
 
Date 
 
By 
1.0 
Initial Submission 
10/SEP/2018 
C. Cain, M. 
McDermott, B. 
Romano, D. White, J. 
McKenzie, K. Davis, 
B. Miller 
2.0 
Response to IRB comments  
20/SEP/2018 
B. Miller 
3.0 
Repeat 
Screening 
Visit 
and 
correction 
to 
overnight 
titration 
protocol 
17/Dec/2018 
B. Miller 
4.0 
Addition of 2 week at home use 
sub-study 
04/APR/2019 
C. Cain, B. Miller, K 
Davis 
5.0 
Update to participant compensation 
for take home portion  
29/APR/2019 
K. Davis, B, Miller 
6.0 
Update to repeat 2 week take home 
15/JUL/2019 
K. Davis, B, Miller 
7.0 
Addition of new research site and 
market research firm 
06/SEP/2019 
B. Fink (previously 
Miller) 
8.0 
Change of PI and clinical site 
29/SEP2019 
B. Fink 
  
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 8 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Glossary 
 
Apnea: the cessation of airflow at the nostrils and mouth for at least 10 seconds.  
Apnea/Hypopnea Index (AHI): the number of apneas and hypopneas per hour of 
sleep.   
Auto Adjusting Continuous Positive Airway Pressure Device: A type of CPAP 
machine that monitors changes in breathing and compensates automatically by making 
appropriate therapeutic adjustments in pressure delivery.  
Average Volume Assured Pressure Support (AVAPS): Positive airway pressure 
support that provides a gradual pressure change based on the average of the preceding 
several breaths. 
Bi-Level PAP Therapy: Responds to both inspiration and expiration by the patient and 
delivers a set amount of pressure when the patient begins spontaneous inhalation and 
decreasing pressure when exhalation begins. 
COPD: Chronic Obstructive Pulmonary Disease 
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. 
Hypersomnolence: Excessive daytime sleepiness. 
ODI: 4% Oxygen Desaturation Index 
EFL: Expiratory Flow Limitation - occurs when the airways become compressed which 
usually results when a pressure outside the airway exceeds the pressure inside the 
airway 
EPAP: 
Expiratory Positive Airway Pressure-Physician prescribed pressure for the 
expiratory (breathing out) phase of an individual on Bi-level PAP therapy  
FEV1: Forced Expiratory Volume in one second – the volume of air exhaled in the first 
second of the FVC maneuver and is the most reproducible measurement of airway 
obstruction. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 9 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
FOT: Forced Oscillation Technique – A method to detect the presence of expiratory flow 
limitation. 
FVC: Forced Vital Capacity – Spirometry measurement in which the patient inhales 
maximally and then exhales as rapidly and completely as possible. 
IPAP: Inspiratory Positive Airway Pressure - Physician prescribed pressure for the 
inspiratory (breathing in) phase of an individual on Bi-level PAP therapy. 
Noninvasive Positive Pressure Ventilation (NPPV):  mechanical ventilation provided 
noninvasively (by mask or similar interface) rather than through an endotracheal tube or 
tracheostomy. 
Positive End Expiratory Pressure (PEEP): Pressure in the lungs (alveolar pressure) 
above atmospheric pressure (the pressure outside of the body) that exists at the end of 
expiration. 
OSA: Obstructive Sleep Apnea - a disorder in which complete or partial obstruction of 
the airway during sleep causes loud snoring, oxyhemoglobin desaturations and frequent 
arousals. 
S Mode: Spontaneous Ventilation – provides ventilation in synchrony with a person’s 
spontaneous breathing efforts; triggering of a breath cycle is only by the patient. 
S/T Mode: Spontaneous Timed Ventilation – provides ventilation in synchrony with a 
person’s spontaneous breathing efforts; triggering of a breath cycle is by the patient or 
the ventilator, should the person fail to trigger the ventilator after a preset time. In 
Spontaneous/Timed mode a "backup" rate is set to ensure that the patient still receives 
a minimum number of breaths per minute if they fail to breathe spontaneously. 
Zrs – total impedance of the respiratory system as measured by the forced oscillation 
technique (FOT) at a forcing frequency of 5 Hz. 
Xrs – the reactance (i.e. the imaginary component of the impedance) of the respiratory 
system as measured by the forced oscillation technique (FOT) at a forcing frequency of 
5 Hz. 
ΔXrs – is the difference between the mean value of Xrs during expiration (
exp
X
) and the 
mean value of Xrs during inspiration (
insp
X
). A breath is classified as flow-limited if its 
ΔXrs is greater than 2.8 
-1
2
L
s
O
cmH


 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 10 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Background Information 
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and 
mortality worldwide.   
Treatment options for COPD patients consist of medications, such as bronchodilators 
and anti-inflammatory drugs, pulmonary rehabilitation, long term oxygen therapy 
(LTOT), lung volume reduction surgery and lung transplantation.  Studies have shown 
that bronchodilators and anti-inflammatory drugs show minor or no benefit on long term 
outcomes but rather are used mainly for symptomatic relief.1  Pulmonary rehabilitation 
has been demonstrated to improve functional status and symptoms but there is lacking 
evidence on long term outcomes of this therapy. 2   Lung volume reduction surgery and 
lung transplantation is only appropriate for a small number of patients; therefore, there 
is no demonstration of improved long-term survival rate.3, 4 
Of these available therapies, few have been shown to significantly improve long term 
patient outcomes.  For the severe COPD patient, LTOT is the only treatment that 
demonstrated prolonged survival in controlled studies. 5, 6   But, despite the effectiveness 
of LTOT, COPD is still characterized by a high morbidity and mortality rate.   
Noninvasive positive pressure ventilation (NPPV) is one therapy that may prove 
beneficial to stable COPD patients.  NPPV is the use of positive pressure ventilation 
administered via a nasal or full face mask (that covers both the nose and mouth).  This 
type of ventilation has become a well-established and increasingly used therapeutic 
option for patients with hypercapnic respiratory failure (HRF) due to COPD.7  
NPPV, used nocturnally, may improve nighttime hypoventilation that is common with 
COPD patients.  An improvement in nocturnal hypoventilation would reset the 
respiratory center sensitivity for CO2.8 9 This would result in an improvement in daytime 
gas exchange and sleep quality.  It is also known that hyperinflation in patients with 
COPD increases their work of breathing, thus fatiguing the respiratory muscles.10 It has 
been suggested that by applying nocturnal NPPV it would allow the respiratory muscles 
to rest, resulting in muscle function recovery, increased respiratory muscle strength, 
reduced the tendency for fatigue and improvement in pulmonary function and gas 
exchange.11   
COPD is a disease that results in varying degrees of dyspnea, or shortness of breath.  
Spirometry is a method of diagnosing COPD with the presence of a post bronchodilator 
FEV1 <80% of the predicted value in combination with an FEV1 / FVC <70%.  This 
would confirm that there is a presence of airflow limitation that is not fully reversible. 
The presence of airflow limitation has been identified as one of the main causes of 
dyspnea in patients with chronic obstructive pulmonary disease (1).  Expiratory Flow 
Limitation (EFL) occurs when the airways become compressed which usually results 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 11 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
when the pressure outside the airway exceeds the pressure inside the airway.  As 
airflow obstruction worsens, EFL appears at much lower flows for a given lung volume 
and it becomes present at rest or at least develops early during exercise (2). 
Early detection of EFL consisted of either invasive esophageal balloon or relatively 
complex plethysmographic techniques.  An alternative approach, and one that will be 
used in this study, involves the Forced Oscillation Technique (FOT).  
In 2003 Dellacà et al. proposed a new method to detect EFL during quiet breathing non-
invasively using the FOT. It was based on the observation COPD patients with EFL 
developed large negative swings in the respiratory system input reactance measured at 
5Hz during expiration. They used this observation to define a sensitive and specific 
method of determining the presence of EFL. Normally the reactance reflects the elastic 
and inertial properties of the respiratory system but when flow limitation is present, the 
oscillatory signal cannot pass through the choke points and reach the alveoli. This 
produces a marked reduction in the apparent compliance and, consequently, a fall in 
Xrs.  
Although this Xrs reduction is present at all the frequencies, the greatest difference is 
seen at the lowest frequency. Since the quiet breathing signal can interfere with the 
estimation of Zrs at frequencies below 5 Hz, this frequency was used for the forcing 
signal. The difference between the mean value of Xrs during inspiration (
insp
X
) and 
exp
X
 , is called
rs
X

. A breath is classified as flow-limited if its Xexp,min is greater than 
2.8 
-1
2
L
s
O
cmH


. 
This technology has been evaluated in numerous clinical studies for both the detection, 
reduction and abolishment of expiratory flow limitation in patients with COPD.  In 1956, 
Dubios et all, demonstrated that the FOT method to be applicable to the measurement 
of airway resistance in patients, evaluation of therapeutic procedures designed to 
relieve airway obstruction, separation of airway resistance from tissue resistance, and 
study of the multiple factors that may affect airway resistance.1 And in additional work 
2006, Dellaca et all, suggested the forced oscillation technique may be useful in chronic 
obstructive pulmonary disease patients using nasal pressure support by identifying 
continuous positive airway pressure levels that support breathing without increasing 
lung volume, as turn increase the work of breathing and reduce muscle effectiveness 
and efficiency. 
                                                          
 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 12 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
The Vector project has incorporated this method as a new feature into the Philips 
Respironics BiPAP Ventilator overall platform (K121623). The device has been 
designed to produce a 5 Hz sine wave with peak to peak amplitude of approximately 2 
cmH2O superimposed upon the pressure and flow generated by the device. The 
resultant feedback waveform is then filtered and analyzed to measure reactance 
(deltaX) and thus determine if EFL is present. Subsequently the EPAP (and 
concurrently and proportionally the IPAP) is increased until the EFL is essentially 
abolished (falls below the predetermined EFL threshold). Since this reactance is 
analyzed continuously (breath by breath) during both inspiration and expiration, it is 
relatively immune to external factors such as modest leaks or coughing / swallowing. 
Description of the Intervention Studied  
The Vector ventilator is intended to provide non-invasive ventilatory support to treat 
adult patients with Respiratory Insufficiency with the primary cause being COPD.  It is 
intended to be used within the home, institutional/hospital, and diagnostic laboratory 
environments. This device is not intended for life support. It can be used to screen for 
the presence, and abolishment of Expiratory Flow Limitation.  
The Vector ventilation method auto-titrates PEEP or EPAP on a breath by breath basis.   
Vector is a new noninvasive method to continuously detect EFL during spontaneous 
breathing and minimizing it using EPAP. 
The device has been designed to produce a 5 Hz sine wave with peak to peak 
amplitude of approximately 2 cmH2O superimposed upon the pressure and flow 
generated by the device. The resultant feedback waveform is then filtered and analyzed 
to detect the change of a reactance (ΔXrs). Subsequently the EPAP (and concurrently 
and proportionally the IPAP) is increased until the EFL is essentially abolished (falls 
below the predetermined EFL threshold). Since this reactance is analyzed continuously 
(breath by breath) during both inspiration and expiration, it is relatively immune to 
external factors such as modest leaks or coughing/swallowing. Given that forced 
oscillation technique can be easily applied during noninvasive nasal ventilatory support, 
it could be used during routine noninvasive ventilation. 
This Vector screening mode is an automated five-minute screening test can be done in 
a clinical environment under supervision to determine if EFL is present. 
The screening test will have built in logic that determines the test’s validity during the 
screening, as well as, the conclusion of the test.  The screening test will be at a 
relatively fixed pressure (typically between 3-4 cmH2O) that will remain constant 
throughout the session.  The screening session results, which will consist of near real-
time pulmonary mechanic information will be kept on a display until the next session is 
enabled. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 13 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Study Design Rationale 
The clinical study is designed primarily as an engineering evaluation to verify the 
software functionality and performance of both the screening and therapy modes of the 
Vector device. This study is necessary in order to confirm the device is functioning as 
designed prior to use in larger clinical trials to support product launch.  
Study Objectives and Purpose  
 
Primary Objective 
The primary objective of the study is to collect engineering pre-therapy screening and 
therapy data on the Vector NIV device via an overnight study on COPD patients that 
have been identified as having EFL. 
 
Study Hypothesis: 
1. Therapy provided by the Vector device will minimize COPD patients’ EFL throughout 
the course of an overnight sleep study 
2. Clinical study staff can operate the Vector device to successfully screen patients for 
EFL and then set up the Vector device to determine the Optimized EPAP required for 
abolishment of EFL 
Study Endpoints: 
 Ventilator-collected parameters during the therapy night such as: Mean EPAP, 
Respiratory Rate, Minute Ventilation, and ΔXrs values. 
 Ventilator-collected parameters during the EFL screening; ΔXrs value, % flow 
limited breaths, mask leak values. 
 SpO2. 
 Patient Therapy comfort assessment via Questionnaires 
 
Study Design: 
This study is a nonrandomized, unblinded overnight engineering clinical evaluation of 
the Vector NIV device in COPD patients with EFL. Up to 50 individuals may be enrolled 
in order to have a total of up to 30 completed participants. Male and female participants 
who qualify per the inclusion/exclusion criteria may be enrolled. 
Potential participants will be identified and recruited from the site database of COPD 
patients.  Potential participants may also be identified by a local marketing company.  
These participants will complete online or phone screenings prior to being seen at the 
clinical site. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 14 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Schedule of Events: 
Participants will be contacted by designated study staff from the site database of COPD 
patients. Participants may be pre-screened over the phone to determine eligibility.  
Participants that are interested will be scheduled for the screening visit at the clinical 
office. 
Potential participants may be also be found by a local marketing company. This 
marketing company will utilize their local database to find potential participants in the 
Pittsburgh, PA area.  These participants will undergo a brief online and/or over the 
phone screening by the marketing company.  If they are found to be potentially eligible, 
Philips Respironics study staff will reach out to the participants.  A more thorough phone 
screen will be conducted by the Philips Respironics study staff.  If the person is still 
found to be potentially eligible for the study and is interested they will either be 
scheduled by the Philips Respironics staff to come into the Pittsburgh Pulmonary 
Physician Practice site or will be contacted by the staff of Consolidated Clinical Trials for 
appointment scheduling.  A waiver of informed consent for screening will be submitted 
to the IRB for contacting these participants.  
Study Visit 1 (screening)   
Once the participant arrives, the study will be explained in full detail.  If the participant 
agrees, he/she will be consented into the study and the participant will be given a copy 
of the informed consent.  
Once consent is obtained and eligibility is confirmed, the following study related 
procedures will be conducted: 
• 
Demographics:  gender, age, ethnicity, height and weight will be collected. 
• 
Current Medications:  all current medications will be collected. 
• 
Medical History Assessment: information will be collected regarding historical 
spirometry data, COPD history and other relevant medical history including the 
diagnosis of sleep disordered breathing. 
• 
Physical examination with vital signs to include HR, BP, RR, SpO2 maintained at 
least 88%, and chest auscultation. 
• 
Administration of CAT and EFL Indication questionnaires 
• 
Mask Fitting:  Participants will have a mask fitting in order to determine the best 
possible provided mask while using the Vector NIV device during the screening for EFL. 
EFL Screening/Determination and EPAP Titration 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 15 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 • 
For the EFL Screening/Determination and EPAP Titration procedure, the study 
device will be set up in fixed pressure mode (Appendix A) for EFL.  
• 
EFL Determination: The participant will be asked to breathe quietly into the 
Vector device using the selected mask for 5 minutes in the seated position, and then an 
additional 5 minutes while in supine or semi-recumbent position.  This device has the 
capability of detecting EFL.  If it is determined that the participant does not have EFL 
after 5 minutes by the device screening indicator, the participant will not continue in the 
study.  
• 
EPAP Titration: if it is determined by the Vector NIV device that the participant 
has EFL, the Vector NIV device will be changed from screening mode to therapy mode 
to delivery BiPAP therapy.  The participant may be changed to a new mask at this time. 
The participants will then breathe on the Vector NIV device in the supine position for 
approximately an additional 20 minutes. During the additional 20 minutes of breathing, 
the device will automatically increase the EPAP (and concurrently and proportionally the 
IPAP) until the EFL is abolished (or falls below the predetermined EFL threshold).  
• 
While the automatic EPAP Titration is being performed, all participants’ SpO2 will 
be monitored via finger pulse oximetry. If the SpO2 persistently falls below 88% during 
the titration, the participant will not be scheduled for study visit 2.  
• 
Patient must stay awake during the EPAP Titration. If the patient, falls asleep, 
they will be woken by study staff. 
• 
The Final EPAP that is determined to abolish the participants EFL will be 
recorded. If the determined EPAP pressure is 6cmH2O or higher, the participant may 
continue to study visit 2. If the determined EPAP is below 6cmH2O, then the participant 
will not be scheduled for study visit 2.  
 EFL Screening Post Visit 1 Questionnaire 
Participants that are determined to have EFL and a titrated EPAP >6cm H2O will be 
scheduled for study visit 2 where they will undergo an overnight sleep study with the 
Vector NIV device in a Sleep Laboratory.  
 
Study Visit 2 (Overnight Sleep Study) (within 28 days of visit 1 +/- 7 days) 
Participants will be asked to report to the sleep lab for an overnight sleep study. 
Participants will be asked to come to the sleep lab at a scheduled date and time in order 
to have the trained sleep technician along with a Philips Respironics engineer prepare 
them for the sleep study and re-acclimate them to the NIV device.   The sleep testing 
will begin near the subject’s usual bedtime and ends at you normal wake-up time. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 16 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
For the sleep study, participants will be set-up with a standard PSG montage that will 
include the following sensors: 
 Two RIP belts secured around the chest and abdomen to measure movements 
associated with breathing effort 
 A small sensor which attaches to the chest belt to measure body position 
 Lead II ECG electrode derivation 
 EEG electrodes attached to the scalp and face to measure sleep stages 
(including at least C4, C3, A1, A2, O1, O2, GND EEG, Left Outer Canthus (LOC) 
and Right Outer Canthus (ROC) EOG and submental EMG) 
 A flexible finger sensor placed on the finger to measure oxygen saturation 
(average signaling time of 3 seconds) 
 A microphone attached to the skin at the base of the neck to measure snoring 
sounds 
 Surface electrodes attached to the skin bilaterally over the anterior tibialis 
muscle, to measure leg movements 
 
Prior to the sleep study with the NIV device, the trained technologists will verify mask 
size, fit, and adjustment that was determined at study visit 1. Patients will be asked to 
bring their previously fitted mask from the study visit 1. Once the sleep testing has 
started, technologists will have a 2 hour window from sleep onset to make any 
additional mask changes or adjustments.   
During the Sleep study, the Vector NIV device will be connected to a laptop computer 
where all Ventilator related parameters collected by the device can be viewed and 
monitored by the sleep technician and the Philips Respironics engineer. These outputs 
include the device IPAP and EPAP pressures, EFL value, patient flow, mask leak, 
minute ventilation, and respiratory rate.  A flexible finger sensor will be placed on the 
finger in order to measure and monitor oxygen saturation 
During the sleep study, the Vector NIV device with the optimized EPAP will be tested in 
periods with both fixed pressure support as well Average Volume Assured Pressure 
Support during the night. In the event that the study participant presents with any 
obstructive or respiratory related events during the sleep study during the Vector 
therapy, the trained sleep technician will be able to make manual adjustments to the 
device pressure settings in order to address the issue (Appendix A). 
In the event that manual titration was unsuccessful, the trained sleep technologist will 
refer to standard of care procedures including, but not limited to, switching to a backup 
device that the sleep lab has available. 
Comfort Assessments:  At the end of the sleep study (within two business days) all 
participants will be asked to complete a comfort questionnaire via phone.  This call will 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 17 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
be conducted by the sponsor study staff. This phone call should last less than 10 
minutes. 
Study participants who complete the overnight sleep study successfully and are  
interested, will be asked to take part in the two week home use sub study. If the 
participant agrees to participate, they will receive one on one training on the Vector NIV 
device and accessories by clinical study staff and/or Philips engineers. They will also be 
given a device user manual. Once trained on the device, study participants will be 
asked to take the device home and use as instructed during the night for a 2 week 
period. Study participants will be given the mask that was used for the overnight sleep 
study to use with the Vector NIV device for the 2 week period.  
-Optional Exit Interview and/or EFL assessment – (within 5 months of visit 1) 
Participants may be asked to return to the clinical study site for an optional  EFL 
screening/determination and/or complete an optional open interview. at any time during 
the study or sub-study. The interview and EFL screening/determination session may be 
videotaped and used for marketing purposes.  Participants will consent to the use of this 
information for these reasons. During the interview, the participant will be asked to 
answer a set of questions about their opinions related to their experience with the 
device in the study. This interview will be conducted by a member of the study staff or 
study sponsor representative.  The interview will require up to an hour of the 
participant’s time.  Participants will be asked to indicate their approval to the interview 
and EFL screening/determination session video recorded prior to being scheduled to 
come into the clinical study site.    
Unscheduled Visits: 
Participants may be asked to participate in this overnight data collection study up to 
three (3) times.  This will occur within a month of the first overnight. 
Vector Home Use Sub Study 
Those participants that successfully completed overnight PSG visits or new participants 
who are currently using a PAP or NIV device at home will be contacted to participate in 
a Sub Study involving overnight home use of the Vector NIV device.   
Sub- Study Primary Objective: 
To evaluate the performance of the Vector NIV device at home for 2 weeks in patients 
with COPD patients that have been identified as having EFL. 
 
Sub-Study Endpoints: 
 Ventilator adherence during 2 week home use sub-study.  

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 18 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 Ventilator-collected parameters during 2 week home use sub-study such as: 
Mean EPAP, Respiratory Rate, Minute Ventilation, and ΔXrs values 
 Patient Therapy Comfort assessment via Questionnaires 
 
Additional Inclusion/Exclusion Criteria: 
Inclusion Criteria: 
1. Participants who completed the initial study and who would be willing to use the 
Vector NIV device at home during the night for a 2 week period OR 
2. Participants prescribed and currently using a PAP or NIV device at home who 
meet study inclusion/exclusion criteria of primary protocol 
 
Exclusion Criteria 
1. Participants currently using a PAP or NIV device at home with a documented 
EPAP setting on their current device that is greater than then the mean or final  
EPAP determined during the therapy session of the screening visit. 
 
Sub-Study Schedule of Events:  
Sub-Study Screening Visit: 
 All study participants will undergo the exact same study procedures as in study 
visit 1 in the primary study with the following differences: 
1. Study participants who are currently  using an NIV or PAP therapy device at 
home that have a EPAP setting that is greater than the mean or final EPAP 
determined during the 20 minute therapy session will not be asked to 
continue onto the 2 week device home use period.  
2. Participants who are currently on NIV or PAP will not be scheduled for an 
overnight PSG.   
3. Once eligibility has been confirmed, participants will receive one on one 
training on the Vector NIV device and accessories by clinical study staff. They 
will also be given a device user manual. Once trained on the device, study 
participants will be asked to take the device home and use as instructed 
during the night for a 2 week period. 
 
Sub-Study Office Visit: 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 19 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 At the end of the 2 week device home use period, study participants will be 
asked to return to the clinical study site to return the study Vector NIV device and 
complete a survey.   
Unscheduled Sub-Study Visits: 
Participants may be asked to repeat the two week take home portion of the study up to 
three (3) times.  This will occur within three months of the sub-study screening visit.  
 
Selection and Withdrawal of Subjects: 
Inclusion Criteria 
1. Age > 40 years of age; < 80 years of age 
2. Ability to provide consent 
3. Diagnosis of COPD 
4. Must present with EFL via screening of the vector device at 3 cmH2O  
5. Have an EPAP to abolish EFL greater or equal to 6cmH2O 
6. Must be able to maintain SpO2 greater than 88% at rest and during EPAP 
Titration 
 
Exclusion Criteria:  
1. Any major non COPD uncontrolled disease or condition, such as congestive 
  heart failure, malignancy, liver or renal insufficiency (that requires current  
  evaluation for liver or renal transplantation or dialysis), amyotrophic lateral     
  sclerosis, or severe stroke, or other condition as deemed appropriate by    
  investigator as determined by review of medical history and / or participant  
  reported medical history 
2. Suffering from a COPD exacerbation at the time of data collection or in the 30   
   days prior to data collection 
3. Self-reported Pregnancy 
4. Employee or family member that is affiliated with Philips Respironics 
5. Currently employed by a manufacturer of respiratory products or family member 
employed by a manufacturer of respiratory products 
6. History of bullous emphysema 
7. History of pneumothorax 
8. Evidence of acute sinusitis or otitis media 
9. Hypotension 
10.    Participants at risk for aspiration of gastric contents 
11.    Epistaxis 
12.    Participants in respiratory failure 
13.    Inability to maintain a patent airway or adequately clear secretions  

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 20 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Withdrawal: 
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: 
• 
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 up to 20 participants successfully complete the study.   
Treatment of Subjects: 
Intended Use  
The Vector ventilator is intended to provide non-invasive ventilatory support to treat 
adult patients with Respiratory Insufficiency with primary cause being COPD.  It is 
intended to be used within the home, institution/hospital, and diagnostic laboratory 
environments. This device is not intended for life support. It can be used to screen for 
the presence, and abolishment of Expiratory Flow  
Limitations/Contraindications: 
 Existing respiratory failure  
 Acute sinusitis, otitis media 
 Hypotension 
 At risk for aspiration of gastric contents 
 Epistaxis, causing pulmonary aspiration of blood 
 Inability to maintain a patent airway or adequately clear secretions  
Monitoring: 
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 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 21 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
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 conduct monitoring 
visits periodically as specified by the monitoring plan. Monitoring will be conduct by trained 
clinical research professionals.  
It has been determined that this study does not require a Data Safety Monitoring Board (DSMB). 
Assessment of Performance  
Device performance will be based on the following recorded Ventilator parameters: 
 Mean EPAP, Respiratory Rate, Minute Ventilation, and ΔXrs  values 
 Ventilator collected parameters during the EFL screening; ΔXrs  value, % flow 
limited breaths, & mask leak values 
Assessment of Safety  
All serious adverse events, occurring during the course of the study will be collected, 
fully documented, and reported to the Institutional Internal Review Board by the site 
Principal Investigator, or sponsor staff. Serious adverse events will be reviewed by the 
Sponsor within 24 hours of the study team being aware of the event.  
All adverse events will be collected and reviewed.  As any events will be reported 
electronically or directly from a person the study team will collect the onset, duration, 
intensity and treatment required, outcome and action taken. In addition to adverse event 
reporting, the study staff will report a summary of the protocol findings, participant 
recruitment, drop-outs, and events to the IRB annually.  
Device Deficiencies  
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. Unanticipated device deficiencies that 
lead to SAE’s will be reviewed with the PI and reported to the IRB as required.  
Statistical Methods  
 
General Considerations 
The purpose of this engineering study is to collect engineering and subjective data on 
the Vector device.  No formal statistical analysis is planned.  Any deviations to this 
approach will be indicated in either a revised protocol or in the study report.  Baseline 
and questionnaire ratings will be summarized with descriptive statistics:  continuous 
data will be presented as averages and standard deviations, and categorical data will be 
presented as frequencies and percentages. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 22 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Participant Disposition 
Participant disposition, including the total number of participants enrolled, completed, 
early terminations and withdrawals, will be presented. A listing will be provided with the 
reasons for discontinuation. 
 
Safety Analysis 
Safety evaluations will be performed by recording clinical adverse events at the time 
originally reported as a part of the study visits.  Adverse events will be provided in data 
listings. 
 
Interim Analysis 
Since this is an engineering evaluation, data will be reviewed during the course of the 
study, but a formal interim analysis does not apply. 
Direct Access to Source Data / Documents  
Only site clinical study staff and approved Philips staff working with the research will 
know the identity of the participants.  All information recorded by the study team and 
provided for analysis will be given a 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. 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 to 
Philips Respironics participants will be assigned a unique code number.   
Results of the study related data, medical history, and information obtained from the 
questionnaire and device data will be reported and received by Philips Respironics.  
Philips Respironics will use participant study data for research purposes to support 
engineering 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.  
Provisions to Protect the Privacy Interests of Participants:  Participants will only 
interact with approved members of the research staff, and will have the option to decline 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 23 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
to provide any information that they are uncomfortable revealing. All research staff (site 
and sponsor) will receive training regarding the protection of human subject data.  
Participant’s medical records will only be accessed after obtaining written consent from 
the participant, and will only be reviewed by members of the research staff for whom 
review of this information is necessary for continued participation in the study (e.g. 
Philips research staff and study investigator reviewing the medical records). 
Case Report Forms  
The site study team will capture information on source documents.  These source 
documents will be provided to the sponsor for data analysis.  Copies of the source will 
remain with the site.  Only staff delegated by the PI will have the ability to enter in, or 
make changes to, the source documents. Data from source documents will be entered 
into spreadsheet by a Philips representative and will be monitored according to 
monitoring plan.  All data collected by the sponsor collected and maintained by the 
sponsor, will be kept confidential, and stored in a secure location if on paper or on a 
secure server or protected device.   
Quality Control and Quality Assurance  
The PI and study personnel will be trained to the study protocol, study product, TMF 
documents, monitoring plan, CRFs and/or eCRFs, direct data reporting, and all Sponsor 
expectations, as applicable. Once complete, training and delegations will be 
documented for PI and study personnel. 
Data queries will be addressed by delegated study personnel and CRF/ eCRFs will be 
reviewed and signed off by PI prior to study closure. Monitoring will be completed in 
accordance with US FDA CFR, as applicable.      
Ethics  
This study will be submitted and reviewed by the Allendale Review Board.  All 
participants will be consented prior to completing the trial. The Primary Investigator will 
review all adverse events as it relates to the study device. 
 
This study will receive approval and oversight from 
Allendale Institutional Review Board 
30 Neck Road 
Old Lyme, Connecticut  
United States 
(860) 434-5872 
  
All data will be kept confidential and in a secure location if on paper or on a secure 
server or device. Only approved study personnel will have access to study related 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 24 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
documents. All electronic data shall be stored in a coded data set.  All paper documents 
shall be kept in a secure area.  Study data and source will be made available for study 
related monitoring or audits by the IRB/IEC, sponsor, or regulatory inspection(s).   
Results of the study related data, and information obtained from the engineering study, 
will be collected, received and reported by Philips Respironics.  Philips Respironics will 
use participant study data for research purposes to support scientific and marketing 
objectives described in this protocol.   
Data Handling and Recordkeeping  
Hard copies of the study will be kept on site for at least 2 years after study completion.  
The sponsor will maintain study records indefinitely. Records will be stored at Iron 
Mountain, a secure information management services company.  
Financing and Insurance  
If the participant is injured during the course of the trial and as a direct result of this trial, 
they should contact the Principal Investigator, William Sims, MD. The participant will be 
directed to seek clinically appropriate medical care for that injury. However, we cannot 
guarantee that the medical care and treatment will be provided without charge or that it 
will be paid for by the participants insurance company, and the costs incurred may 
ultimately be the participant’s responsibility.  
 
Registration on ClinicalTrials.gov or other applicable registry  
As this is engineering clinical evaluation, this will not be registered on ClinicalTrials.gov 
or other applicable registry. 
Risk and Benefit Analysis  
 
Potential Risks and Discomforts 
 
This is a minimal risk study.  Potential risks are detailed below and will be listed in the 
ICF and discussed during the consenting process. 
 
The risks of providing noninvasive ventilation with the Vector NIV device are no greater 
than the risks encountered with other assisted positive airway pressure (PAP) devices. 
There are no significant risks will be posed to the participants participating in this 
protocol, as the device is a non-significant risk device and the study is non-invasive and 
will be conducted in a sleep lab and monitored by a trained clinical staff as well as 
Philips Respironics engineer. The equipment has been tested to ensure safety. Should 
the equipment not perform as designed, therapy could increase and / or decrease more 
than desired. This affect could be uncomfortable or awaken the participant.  

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 25 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
A trained clinician will be present monitoring the participant while the device is in use 
the sleep lab. The clinician will intervene should any problems be identified. One 
possible intervention could be for the clinician to stop the study in the event that 
participant’s oxygen saturation (SpO2) falls below 88%. The participant can also easily 
remove their interface device should it become uncomfortable or make breathing 
difficult. Other potential side effects of PAP therapy may include: ear discomfort, 
conjunctivitis, skin abrasions due to non-invasive interfaces and gastric distension 
(aerophagia), all of which are quite uncommon. Thus, we believe that the risks and 
discomfort are minimal. All masks used for this study are commercially available 
products.  
Oxygen saturations (SpO2) will be monitored throughout the duration of the nocturnal 
study.  
The patient may sleep poorly during the nocturnal sleep study and thus may be sleepy 
the next day. If the patient is too sleepy to drive home, other forms of transportation will 
be utilized. 
Should any problems be identified during the 2 week home use period, participants can 
easily remove their mask interface during the night and discontinue use of the Study 
Vector NIV device. Those study participants who are on existing PAP or NIV therapy will 
be instructed to resume use with their current device.  
 
Potential Benefits 
Although participation in this trial will not result in any direct benefit to the subject, they 
will be contributing to generalizable data that will help improve device design and 
function. 
Compensation for Research-Related Activities 
Participants will only be compensated for the activities that they complete. Participants’ payment 
will be maded according to the following schedule. 
Activity 
Payment Amount 
Payment Timing 
Screening Visit 
$50 
Within 6 weeks after visit 
Overnight Sleep study visit 
$200 
Within 6 weeks after visit 
Optional Exit Interview visit 
$50 
Within 6 weeks after visit 
SubStudy Visit 1 
$50 
Within 6 weeks after visit 
2 week take home 
$50/week 
Within 6 weeks after visit 
Completion of SubStudy Exit 
Interview 
$50 
Within 6 weeks after visit 
 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 26 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
Publication  
 
At this time, there are no planned publication submissions for this study. 
References  
 
1. Rennard SI, Serby CW, Ghafouri M, et al. Extended therapy with ipratropium is 
associated with improved lung function in patients with COPD. Chest 1996; 110: 62-70 
2. Reis AL, Kaplan RM, Limberg TM, et al. Effects of pulmonary rehabilitation on 
physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary 
disease. Ann Intern Med 1995; 122: 823-832 
3. Lung transplantation: report of the ATS workshop on lung transplantation: American 
Thoracic Society, Medical Section of the American Lung Association. Am Rev Respir 
Dis 1993; 147: 772-776 
4. Benditt JO, Albert RK. Lung reduction surgery: great expectation and a cautionary 
note. Chest 1995; 107: 297-298 
5. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung 
disease: a clinical trial: Nocturnal Oxygen Therapy Trial Group. Ann Intern Med 1980; 
93: 391-398 
6. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating 
chronic bronchitis and emphysema: report of the Medical Research Council working 
party. Lancet 1981; 1: 681-686 
7. Windisch W., et al, Outcome of Patients with Stable COPD Receiving Controlled 
Noninvasive Positive Pressure Ventilation Aimed at a Maximal Reduction of PaCO2. 
Chest 2005; 128: 657-662  
8. Douglas NJ, Calverley PMA, Legget RJE, et al. Transient hypoxaemia during sleep in 
chronic bronchitis and emphysema. Lancet 1979; 1: 1-4 
9. Roussos C. Function and fatigue of respiratory muscles. Chest 1985; 88: 124S-132S 
10. Hill N, Leger P, Criner G. Clinical indications for noninvasive positive pressure 
ventilation in chronic respiratory failure due to restrictive lung disease, COPD, and 
nocturnal hypoventilation – a consensus conference report. Chest 1999; 116: 521-534 
11. Braun NM, Marino WD. Effect of daily intermittent rest of respiratory muscles in 
patients with severe chronic airflow limitation (CAL). Chest 1984; 85: 59S-60S 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 27 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
12. Budweiser S, Heidtkamp F, Jorres RA, Heinemann F, Arzt M, Schroll S, et al. 
Predictive significance of the six-minute walk distance for long-term survival in chronic 
hypercapnic respiratory failure. Respiration  2008; 75: 418-26. 
13. Steier J, Kaul S, Seymour J, Jolley C, Rafferty GF, Man WD-C, et al. The Value of 
Multiple Tests of Respiratory Muscle Strength. Thorax. 2007;62:975-80. 
14. Steier J, Jolley CJ, Seymour J, et al. Neural respiratory drive in obesity. Thorax 
2009; 64: 719-25. 
15. Jolley CJ, Luo YM, Steier J, et al. Neural respiratory drive in healthy subjects and in 
COPD. European Respiratory Journal 2009; 33: 289-97. 
16. Read DJ. A clinical method for assessing the ventilatory response to carbon dioxide. 
Australas Ann Med 1967; 16: 20-32 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 28 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
Appendix A 
 
MANUAL TITRATION PROTOCOL 
 
Vector Device Settings Fixed Pressure: 
 Pressure Support 
 
            
6 cmH2O  
 Max Pressure 
 
 
 
26 cmH2O 
 EPAP Min / EPAP Max 
 
 
4 / 20 cmH2O  
 
 
 
 
 
Vector Device Setting – AVAPS 
 Target Tidal Volume  
 
 
8 ml/kg of ideal body weight  
 Pressure Support Min / Max 
 
4 / 15 cmH2O  
 Max Pressure 
 
 
 
35 cmH2O 
 EPAP Min / EPAP Max 
 
 
4 / 20 cmH2O  
 
 
 During the both the Fixed Pressure Support and AVAPS portion of the sleep 
study, if the participant has persistent obstructive events with SpO2 nadir less 
than 88% during events that is not fixed by the device over a 30 minute period of 
time, then the sleep technician may increase EPAP min at increments of 1-2 cm 
H2O every 5 minutes to try and correct the obstructive events.  If the participant 
persists to have respiratory events with the SpO2 nadir less than 88% despite the 
Vector algorithm-based EPAP changes and the manual increments to EPAP min, 
then the participant may be withdrawn from the study. 
 Once the auto algorithm has settled (~2 hours after sleep initiated), if SpO2 
remains low, tidal volume adjustments can be made (up to 10ml/kg IBW) based 
on the sleep lab technician’s discretion. 

 
Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients  
Version 8.0- 29Sep2019 
Page 29 of 29 
Confidential 
Protocol # SRC-HRC-Vector ENG -2018-10241 
 
 
 
  
 
 
AVAPS Tidal Volume Setting * Based on 8ml/kg 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* Based on 8ml/kg IBW 
Dr. BJ Devine IBW formula (1974)  
Men: Ideal Body Weight (kilograms) = 50 + 2.3kg per inch over 5 feet 
Women: Ideal Body Weight (kilograms) = 45.5 + 2.3kg per inch over 5 feet 
 
Height 
Male 
Female 
5’0” 
400 
360 
5’1” 
420 
380 
5’2” 
440 
400 
5’3” 
460 
420 
5’4” 
470 
440 
5’5” 
490 
460 
5’6” 
510 
470 
5’7” 
530 
490 
5’8” 
550 
510 
5’9” 
570 
530 
5’10” 
580 
550 
5’11” 
600 
570 
6’0” 
620 
580 
6’1” 
640 
600 
6’2” 
660 
620 
6’3” 
680 
640 
6’4” 
690 
660 
6’5” 
710 
680 
6’6” 
730 
700