Feasibility Of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors
Phase: NA
Conditions: Postoperative Pulmonary Complications (PPCs)
Sponsor: National Institutes of Health Clinical Center (CC)

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Abbreviated Title: Wearable Incentive Spirometry 
NIH IRB #: IRB001915 
Version Date: September 8, 2025 
Title: Feasibility of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors 
Principal Investigator:    
NIH Principal Investigator: Peter Pinto, M.D. 
Urologic Oncology Branch  
National Cancer Institute (NCI)   
Building 10, Room 2-5952   
10 Center Drive   
Bethesda, MD 20892   
Phone: 240-858-3700   
E-mail: pp173u@nih.gov  
 
 
 
 
 

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TABLE OF CONTENTS  
TABLE OF CONTENTS ................................................................................................................ 2 
STATEMENT OF COMPLIANCE ................................................................................................ 6 
1 
PROTOCOL SUMMARY ...................................................................................................... 7 
1.1 
Synopsis ........................................................................................................................... 7 
1.2 
Schema ............................................................................................................................. 9 
2 
INTRODUCTION ................................................................................................................ 10 
2.1 
Study Background and Rationale ................................................................................... 10 
2.2 
Risk/Benefit Assessment ................................................................................................ 11 
2.2.1 
Known Potential Risks ............................................................................................ 11 
2.2.2 
Known Potential Benefits ....................................................................................... 11 
2.2.3 
Assessment of Potential Risks and Benefits ........................................................... 11 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................... 11 
4 
STUDY DESIGN.................................................................................................................. 12 
4.1 
Overall Design................................................................................................................ 12 
4.2 
Scientific Rationale for Study Design ............................................................................ 12 
4.3 
Justification for Intervention .......................................................................................... 12 
4.4 
End-Of-Study Definition ................................................................................................ 12 
4.5 
Device Information ........................................................................................................ 13 
4.5.1 
Motion Sensor - 10-axis Bluetooth Gyro Inclinometer .......................................... 13 
4.5.2 
Incentive Spirometer - Teleflex Medical ................................................................ 13 
5 
STUDY POPULATION ....................................................................................................... 13 
5.1 
Inclusion Criteria ............................................................................................................ 13 
5.2 
Exclusion Criteria ........................................................................................................... 13 
5.3 
Inclusion of Vulnerable Participants .............................................................................. 14 
5.3.1 
Participation of NIH Staff or family members of study team members ................. 14 
5.4 
Inclusion of Pregnant Women, Fetuses Or Neonates ..................................................... 14 
5.5 
Lifestyle Considerations ................................................................................................. 14 
5.6 
Screen Failures ............................................................................................................... 14 
5.7 
Strategies for Recruitment and Retention ...................................................................... 14 
5.7.1 
Costs ........................................................................................................................ 15 
5.7.2 
Compensation ......................................................................................................... 15 

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STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ................... 15 
6.1 
Study Interventions(s) or Experimental Manipulations(s) Administration .................... 15 
6.1.1 
Study Intervention or Experimental Manipulation Description.............................. 15 
6.1.2 
Administration ........................................................................................................ 15 
6.2 
Fidelity ........................................................................................................................... 15 
6.2.1 
Interventionist Training and Tracking .................................................................... 15 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................... 15 
6.4 
Study Intervention/Experimental Manipulation Adherence .......................................... 15 
6.5 
Concomitant Therapy ..................................................................................................... 15 
6.5.1 
Rescue Therapy ....................................................................................................... 15 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ................................................ 16 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation .............................. 16 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................... 16 
7.3 
Lost to Follow-up ........................................................................................................... 16 
8 
STUDY ASSESSMENTS AND PROCEDURES ................................................................ 16 
8.1 
Screening Procedures ..................................................................................................... 16 
8.1.1 
Screening activities performed prior to obtaining informed consent ...................... 16 
8.1.2 
Screening activities performed after a consent for screening has been signed ....... 16 
8.2 
Study Evaluations & Procedures .................................................................................... 16 
8.2.1 
Biospecimen Evaluations ........................................................................................ 17 
8.2.2 
Samples for Genetic/Genomic Analysis ................................................................. 17 
8.3 
Safety Assessments ........................................................................................................ 17 
8.4 
Adverse Events and Serious Adverse Events ................................................................. 17 
8.4.1 
Definition of Adverse Event ................................................................................... 17 
8.4.2 
Definition of Serious Adverse Events (SAE) ......................................................... 17 
8.4.3 
Classification of an Adverse Event ......................................................................... 17 
8.4.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 18 
8.4.5 
Adverse Event Reporting ........................................................................................ 19 
8.4.6 
Serious Adverse Event Reporting ........................................................................... 19 
8.4.7 
Events of Special Interest........................................................................................ 19 
8.4.8 
Reporting of Pregnancy .......................................................................................... 19 

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8.5 
Unanticipated Problems ................................................................................................. 19 
8.5.1 
Definition of Unanticipated Problems .................................................................... 19 
8.5.2 
Unanticipated Problem Reporting........................................................................... 19 
9 
STATISTICAL CONSIDERATIONS.................................................................................. 19 
9.1 
Statistical Hypothesis ..................................................................................................... 19 
9.2 
Sample Size Determination ............................................................................................ 19 
9.3 
Populations for Analyses ................................................................................................ 20 
9.4 
Statistical Analyses ........................................................................................................ 20 
9.4.1 
General Approach ................................................................................................... 20 
9.4.2 
Analysis of the Primary Endpoints ......................................................................... 20 
9.4.3 
Analysis of the Secondary Endpoint(s)................................................................... 20 
9.4.4 
Safety Analyses ....................................................................................................... 20 
9.4.5 
Sub-Group Analyses ............................................................................................... 21 
9.4.6 
Tabulation of individual Participant Data ............................................................... 21 
9.4.7 
Exploratory Analyses .............................................................................................. 21 
10 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ............ 21 
10.1 
Informed Consent Process .......................................................................................... 21 
10.1.1 Consent Procedures and Documentation ................................................................ 21 
10.1.3 Considerations for Consent of NIH staff, or family members of study team members
 
22 
10.1.4 Consent of Subjects who Are, Or Become, Decisionally Impaired ........................ 22 
10.2 
Study Discontinuation and Closure ............................................................................ 22 
10.3 
Confidentiality and Privacy ........................................................................................ 23 
10.3.1 Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing 
Policies 23 
10.3.2 Certificate of Confidentiality .................................................................................. 24 
10.4 
Future use of Stored Specimens and Data .................................................................. 24 
10.5 
Safety Oversight ......................................................................................................... 24 
10.6 
Clinical Monitoring .................................................................................................... 24 
10.7 
Quality Assurance and Quality Control ...................................................................... 25 
10.8 
Data Handling and Record Keeping ........................................................................... 25 
10.8.1 Data Collection and Management Responsibilities ................................................ 25 
10.8.2 Study Records Retention......................................................................................... 25 

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Protocol Deviations and Non-Compliance ................................................................. 25 
10.10 
Human Data Sharing and Publication ........................................................................ 26 
10.10.1 NIH Public Access Policy Compliance .................................................................. 26 
11 ABBREVIATIONS .............................................................................................................. 26 
12 REFERENCES ..................................................................................................................... 28 
 
 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
• United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study. In addition, all changes to the consent form will be IRB-approved; an 
IRB determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 

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PROTOCOL SUMMARY 
1.1 
SYNOPSIS 
Title: 
Feasibility of Measuring Volume of Inspiration Via Non-Invasive 
Motion Sensors 
Study Description: 
This protocol is a basic physiologic proof-of-concept study enrolling 
normal volunteers to determine the feasibility of measuring volume of 
inspiration from chest wall motion measured via non-invasive thoracic 
motion sensors. The motion sensors are not medical devices because 
they are not intended to diagnose a disease or condition or to cure, 
mitigate, treat or prevent disease. Since motion sensors are not being 
evaluated for diagnostic purposes or being studied themselves within 
the context of this protocol and are only intended to collect 
physiological data, they are not to be considered investigational. The 
data collected in this feasibility study will not contain any personally 
identifiable information (PII). In this study, healthy participants will 
complete a total of approximately 18 measured breaths through a 
traditional incentive spirometer while wearing small, non-invasive 
motion sensors on their thorax at approximately the level of the 9th and 
10th ribs unilaterally or bilaterally. The incentive spirometer is an FDA 
approved medical device. This study does not aim to study the safety or 
effectiveness of this device but rather utilize the device as a tool to 
measure volume of inspiration. The waveform data collected from the 
devices with each breath will then be analyzed with the intention to 
develop an algorithm that could convert chest wall motion to a discrete 
volume of inspiration in real time. Total enrollment time will be about 
10-30 minutes per participant. 
Objectives: 
 
Primary:  
To collect chest wall motion data corresponding to various volumes of 
inspiration from a non-invasive wearable device. 
Secondary:  
To develop an algorithm which can convert chest wall motion to 
volume of inspiration and assess the algorithm using cross-validation 
strategy. 
Endpoints: 
Primary:  
A database of motion waveforms corresponding to each measured 
volume of inspiration via traditional incentive spirometer.  
Secondary:  
A cross-validated algorithm that converts chest wall motion to volume 
of inspiration.  
Study Population: 
Healthy volunteers of both sex and demographic groups who are ages 
18 and older. 

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Description of 
Sites/Facilities Enrolling 
Participants: 
All participants will be healthy volunteers recruited at the NIH.  
Study Duration: 
1 month 
Participant Duration: 
15-30 minutes 
 
 
 

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1.2 
SCHEMA 
Participation Flow Diagram 
 
Flow diagram alt text:  
1. Participants will be consented at the start of the meeting and provided a study ID to 
ensure patient confidentiality.  
2. Each participant will then fill out a form with their study ID, age, sex, height, weight.  
3. The small motion sensor will then be placed unilaterally or bilaterally on the patient’s 
thorax at approximately the level of the 9th and 10th ribs at the mid-axillary line using 
hypoallergenic double-sided adhesive tape. 
4. With the motion sensor is in place, the participant will then take breaths through a 
traditional FDA approved incentive spirometer. They will ideally complete three breaths 
at each of the following volumes: 250mL, 500mL, 1000mL, 1500mL, 2000mL, and 
2500mL.  
5. Upon completion, the motion sensor will be removed, and the participant will be free to 
go with no future scheduled appointments or follow-up. 
 

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 INTRODUCTION 
1.3 
STUDY BACKGROUND AND RATIONALE 
Postoperative pulmonary complications (PPCs) encompass a broad and heterogenous spectrum 
of conditions which serve as a leading cause of suboptimal surgical outcomes globally. 
Approximately 10-20% of the 310 million patients undergoing surgery each year will develop a 
PPC [1-6], and up to 25% of all deaths occurring within one week post-operatively attributed to 
PPCs [4]. These pulmonary complications, which range from minor respiratory alterations to 
severe conditions like pneumonia or respiratory failure, are a culmination of changes to the 
respiratory system that begin immediately after induction of general anesthesia. While under 
general anesthesia, patients experience decreased respiratory drive, reduced lung volumes, and 
altered ventilation perfusion relationship. The addition of a neuromuscular blocking drug for 
general anesthesia further increases risk for PPC with up to 75% of patients developing some 
degree of atelectasis post-operatively [7, 8]. The pain and fatigue many patients encounter post-
operatively amplify the risk of PPCs, as patients become more hesitant to take deep, lung-
expanding breaths. Considering these elements, it stands to reason that PPCs substantially 
influence prolonged hospital stays, elevated healthcare expenditures, and a deterioration in 
holistic patient outcomes.  
Incentive spirometry (IS) has traditionally served as a cornerstone in the prophylaxis and 
management of PPCs. The incentive spirometer works by emulating a natural deep breath, 
serving simply as a visual tool for both patients and providers to gauge the quality and depth of 
lung expansion. The device does not offer any added resistance to assist in alveoli opening. By 
promoting voluntary deep breathing, the device helps to improve pulmonary function, maintain 
alveolar inflation, and enhance the clearance of secretions [9-11]. Despite its widespread 
acceptance in clinical practice, recent literature has shed light on various limitations associated 
with conventional incentive spirometry [12, 13]. Some of these drawbacks include patient 
compliance, nursing burden, and the lack of data storage for longitudinal tracking. Without a 
means to quantitatively assess patient effort and progress, it becomes difficult to assess the true 
impact of incentive spirometry on patient outcomes.  
The continual advancements of digital health technologies and artificial intelligence present a 
compelling opportunity to address these gaps. Some efforts have been made by other groups to 
correlate chest wall motion with lung function, particularly in the asthma and apnea monitoring 
spaces. One group was successful in measuring respiration rate and lung volume using wearable 
strain sensors on a small cohort of volunteers. Others have detected respiratory rate via acoustic 
adhesive sensors on the neck [14] or detected changes in respiratory effort during sleep via an 
elastic band around the thorax and corresponding sensor measuring stretch patterns [15]. It is 
possible that we might identify unique patterns in chest wall motion via motion sensors adhered 
to the patient’s thorax to easily measure and track volume of inspiration and respiratory effort 
post-operatively. This technology could open a door to improved IS compliance and may result 
in decreased nursing burden and improved post-operative management. If successful, it is 
possible that a wearable motion sensor could serve as a substitute for incentive spirometry with 
features to improve patient compliance, facilitate longitudinal IS data collection, and reduce 
burden on nursing staff who continuously have to provide incentive spirometers and remind 
patients to use them.  

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1.4 
RISK/BENEFIT ASSESSMENT 
1.4.1 Known Potential Risks 
There only known risk to the participant is the development of a skin reaction or allergy to the 
hypoallergenic double-sided tape. Participants included in this study will be screened and 
excluded for known allergies to adhesives to mitigate this risk. 
1.4.2 Known Potential Benefits 
This study may not benefit specific study participants, but the results may help the investigators 
learn about the use of motion sensors to improve recording and tracking of post-operative 
incentive spirometry exercises and may potentially aid in post-operative management of future 
patients. 
1.4.3 Assessment of Potential Risks and Benefits 
The potential knowledge that may result from this study is considerable and may balance any 
potential risks to the participants. Proving that it is possible to detect volume of inspiration and 
respiratory rate from a non-invasive, wearable motion sensor could inform future studies which 
might work to improve IS compliance, data transmission, longitudinal tracking, and nursing 
burden. 
OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To collect chest wall motion 
data corresponding to various 
volumes of inspiration from a 
non-invasive wearable device. 
 
A database of motion 
waveforms corresponding to 
each measured volume of 
inspiration via traditional 
incentive spirometer. 
The primary goal of this 
study is to collect data to 
correlate changes in chest 
wall motion with volume of 
inspiration. The first step in 
doing so is the creation of a 
database with this 
information. 
Secondary 
 
 
To develop an algorithm 
which can convert chest wall 
motion to volume of 
inspiration and assess the 
algorithm using cross-
validation strategy. 
A cross-validated algorithm 
that converts chest wall motion 
to volume of inspiration. 
This endpoint will allow us 
to prove the ability to 
calculate volume of 
inspiration from chest wall 
motion and assess its 
accuracy. 
 

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STUDY DESIGN 
1.5 
OVERALL DESIGN 
Healthy volunteers (n = 30) will be recruited for participation in this proof-of-concept study. 
Each participant will be consented and assigned a study number to ensure that all data is non-PII. 
Participants will be asked to fill out a de-identified form with their age, sex, height and weight 
prior to application of motion sensor (see section 1.6).  
Each participant will wear the devices for approximately 10-30 minutes while they perform a 
series of breathing exercises. The thoracic wearable will be adhered unilaterally or bilaterally at 
approximately the level of the 9th and 10th ribs at the mid-axillary line. Hypoallergenic double-
sided tape will be used to adhere the motion sensor to the volunteers’ torso in this position. The 
participant will ideally take three breaths through a traditional incentive spirometer while 
wearing the devices at each of the following volumes: 250mL, 500mL, 1000mL, 1500mL, 
2000mL, and 2500mL. Each breath will be held for approximately 5 seconds before being 
released. Throughout this period, the thoracic wearable will be detecting chest wall expansion. 
All data will be transmitted to a secure server located within the NIH clinical center for analysis 
and model creation. Upon completion of the breathing exercises, the device will be removed 
from the participant, and the participant will be free to leave. There will be no further study visits 
or contact required. 
1.6 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
This is a basic physiologic proof-of-concept study to determine the feasibility of using a motion 
sensor to indirectly measure volume of inspiration. As such, there is no control group. The study 
design is appropriate to meet the goals of this study which are to acquire motion data from 
people taking measured breaths through traditional incentive spirometer.  
1.7 
JUSTIFICATION FOR INTERVENTION 
The entire duration of study participation is 10-30 minutes, making this an incredibly low-
commitment study for healthy volunteers. Minimum acceptable study participation is completion 
of the demographic information at least one attempt of all measured lung volumes, as it is 
possible that some participants will not be capable of taking the maximal volume of inspiration. 
1.8 
END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the 
demographic form and attempted all volumes of inspiration with the motion sensor in place.  
Should the results of this basic physiologic proof-of-concept study be successful, future analysis 
of the technology developed (algorithm) would be submitted under a new IDE protocol to 
perform a study on a larger scale using this device and the algorithm which would be developed  
and marketed to assist in diagnosis, likely be considered a medical device at that time beholden 
to 21 CFR 812, used off label and likely would be NSR along with the algorithm that is 
developed.  
 

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1.9 
DEVICE INFORMATION 
1.9.1 Motion Sensor - 10-axis Bluetooth Gyro Inclinometer 
The motion sensor is the “10-axis Bluetooth Gyro Inclinometer” by Wit Motion and is marketed 
for “rehabilitation exercises, workplace injury prevention, patient care, and healthy shortrange 
wireless motion measurements.” The sensor is 2.02”x1.41”x0.59” and contains a rechargeable 
3.7V Li-batter with a working time of approximately 4 hours. The casing is “indoor/outdoor, 
waterproof, dustproof, anti-UV and vibration resistant.” The data output includes 3 axis 
(acceleration, gyro, angle, magnetic, and quaternion) and 1-axis barometer, air pressure, height 
data. Data is transmitted via Bluetooth 2.0. The device is not being studied for safety and 
effectiveness but is, rather, a tool for collecting basic physiologic data. 
1.9.2 Incentive Spirometer - Teleflex Medical 
An incentive spirometer is a device that measures the volume of the air inhaled into the lungs 
during inspiration. When breathing in through a volume-oriented incentive spirometer, a piston 
rises inside the device and measures the volume of the inspired air. The incentive spirometry device 
is widely used in physical, speech, and respiratory therapy as it encourages the patient to perform 
a slow and deep inspiration through visual feedback.[16] The incentive spirometer is FDA 
approved and will be used on label to collect physiological data and not evaluated for safety and 
efficacy or diagnostic purposes in support of labeling changes. The specific spirometer used for 
this study is the Hudson RCI 2500 VOLDYNE Volumetric Exerciser (REF 8884719011) 
manufactured by Teleflex Medical (Morrisville, NC USA). 
STUDY POPULATION 
1.10 INCLUSION CRITERIA 
In order to be eligible to participate in this proof-of-concept study, an individual must meet all 
the following criteria:  
1. Provision of signed and dated informed consent form.  
2. Stated willingness to comply with all study procedures and availability for the duration of 
the study.  
3. Male or female sex, aged 18-100  
4. Ability of subject to understand and the willingness to sign a written informed consent 
document. 
1.11 EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this 
study:  
1. Pregnancy.  
2. Known allergic reactions to adhesive.  
3. Patients with an altered mental status that precludes understanding and consenting for the 
procedure and compliance with the study activities. 
4. Patients with known pulmonary conditions including pulmonary fibrosis, asthma, COPD, 
or chronic bronchitis.  

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1.12 INCLUSION OF VULNERABLE PARTICIPANTS 
The study is designed to recruit healthy volunteers and we will not be including incapacitated 
adults. 
1.12.1 Participation of NIH Staff or family members of study team members 
NIH staff and family members of study team members may be enrolled in this study as this 
population meets the study entry criteria. NIH staff will not be recruited by their principal 
investigator or superior. Neither participation nor refusal to participate as a subject in the 
research will have an effect, either beneficial or adverse, on the participant’s employment or 
position at NIH. 
Every effort will be made to protect participant information, but such information may be 
available in medical records and may be available to authorized users outside of the study team 
in both an identifiable an unidentifiable manner. 
The NIH Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in 
NIH Research will be made available. Please see section 1.34.3 for consent of NIH Staff. 
1.13 INCLUSION OF PREGNANT WOMEN, FETUSES OR NEONATES 
This study will not include pregnant women. Women will be screened verbally for pregnancy 
and asked to sign a clause on the consent document attesting to being not pregnant. Pregnancy 
causes changes in breathing given added pressure on abdomen + diaphragm. As such, their data 
would likely skew data analysis with an N=30. 
1.14 LIFESTYLE CONSIDERATIONS 
Not applicable. 
1.15 SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently entered in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants, to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, 
and any serious adverse event (SAE). 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened. Rescreened participants should be assigned the same participant number as for the 
initial screening. 
1.16 STRATEGIES FOR RECRUITMENT AND RETENTION 
Healthy adults of both sex, races, and ethnicities at the NIH will be recruited for participation in 
the study. The NIH will be the only study site included. We anticipate recruitment of 
approximately 30 volunteers. Volunteers will be made aware of this study through word of 
mouth and through the assistance from the Office of Patient Recruitment. Peer recruitment is 
proposed as an optimal method for our preliminary proof-of-concept study on the basic 
physiology of breathing given its small scale, lack of PII, short duration, and lack of invasive 
procedures. More robust recruitment of a broader population could be accomplished under a 

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future protocol if the findings of this proof-of-concept study is successful. Recruitment will be 
conducted on a peer-to-peer level with no individuals being recruited by an individual at a higher 
level of authority.  Additionally, all peer recruiting activities will be structured to safeguard 
against risks such as undue pressure or the accidental disclosure of private health information, 
ensuring the protection and voluntary participation of all involved. 
1.16.1 Costs 
There will be no cost associated with participation. 
1.16.2 Compensation 
No compensation will be provided to the subjects. Research results will be made publicly 
available at the conclusion of this study. 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
1.17 STUDY INTERVENTIONS(S) OR EXPERIMENTAL MANIPULATIONS(S) ADMINISTRATION 
1.17.1 Study Intervention or Experimental Manipulation Description 
All participants will be included in the interventional or experimental group for this study. There 
is no control group. The intervention includes the application of a small motion sensor placed on 
the patient’s chest at approximately the level of the 9th and 10th ribs at approximately the mid-
axillary line using hypoallergenic double-sided adhesive tape. With the motion sensor in place, 
the participant will then take breaths through a traditional FDA approved incentive spirometer. 
They will ideally complete three breaths at each of the following volumes: 250mL, 500mL, 
750mL, 1000mL, 1500mL, 2000mL, and 2500mL. Upon completion, the motion sensor will be 
removed, and the participant will be free to go with no future scheduled appointments or follow-
up.  
1.17.2 Administration  
Refer to section 1.17.1 for more details. 
1.18 FIDELITY 
1.18.1 Interventionist Training and Tracking 
N/A.  
1.19 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Participants will not be randomized or blinded for this proof-of-concept study. 
1.20 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
N/A. 
1.21 CONCOMITANT THERAPY 
Not applicable. 
1.21.1 Rescue Therapy 
N/A 

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STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL  
1.22 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
Given the nature and design of this study (lasting approximately 10-30 minutes), discontinuation 
from the study intervention (the motion sensor) will mean discontinuation from the study. If any 
partial motion data or recorded demographic data have been collected prior to decision to 
discontinue the intervention, it will be shredded or deleted.  
1.23 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request.  
An investigator may discontinue or withdraw a participant from the study for the following 
reasons: 
• If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
• If the participant repeatedly fails to show up to their appointment  
• Screen Failure 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
Case Report Form (CRF). 
1.24 LOST TO FOLLOW-UP 
There will be no follow-up associated with this study. 
STUDY ASSESSMENTS AND PROCEDURES 
1.25 SCREENING PROCEDURES 
1.25.1 Screening activities performed prior to obtaining informed consent 
Minimal risk activities that may be performed before the subject has signed a consent include the 
following:  
• Email, written, in person or telephone communications with prospective subjects.  
1.25.2 Screening activities performed after a consent for screening has been signed 
N/A 
1.26 STUDY EVALUATIONS & PROCEDURES 
All patients consented for participation will undergo the following procedures:  
1. Recording self-reported age, sex, height, and weight.  
2. Application of the motion sensor using a medical grade double sided adhesive.  
3. While seated, each participant will ideally take three breaths at each of the following 
volumes through a traditional FDA approved incentive spirometer: 250mL, 500mL, 1000mL, 
1500mL, 2000mL, and 2500mL. The participants will hold each breath for approximately 5 
seconds before exhaling.  
4. Data collection will include motion data transmitted from the motion sensor to a secure 
NIH server.  

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None of this data will be transmitted back to the participants themselves. All findings associated 
with this study will, however, be made publicly available upon the completion of this study.  
1.26.1 Biospecimen Evaluations 
N/A.  
1.26.2 Samples for Genetic/Genomic Analysis 
N.A.  
1.27  SAFETY ASSESSMENTS 
All participants will be verbally screened for pregnancy and a history of skin allergy to adhesives 
to reduce risk of adverse effects.  
1.28 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS  
1.28.1 Definition of Adverse Event 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
1.28.2 Definition of Serious Adverse Events (SAE) 
An adverse event or suspected adverse reaction is considered "serious" if, in the view of either 
the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct normal life functions, or a 
congenital anomaly/birth defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such medical 
events include allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse. 
1.28.3 Classification of an Adverse Event 
1.28.3.1 Severity of Event 
For adverse events (AEs) not included in the protocol defined grading system, the following 
guidelines will be used to describe severity.  
• Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities.  
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. Of note, the term “severe” does not necessarily equate to “serious”.] 

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1.28.3.2 Relationship to Study Intervention/Experimental Manipulation 
All adverse events (AEs) will have their relationship to study procedures, including the 
intervention, assessed by an appropriately trained clinician based on temporal relationship and 
his/her clinical judgment. The degree of certainty about causality will be graded using the 
categories below.  
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
1.28.3.3 Expectedness  
A clinician with appropriate expertise in allergic dermatitis will be responsible for determining 
whether an adverse event is expected or unexpected. An AE will be considered unexpected if the 
nature, severity, or frequency of the event is not consistent with the risk information previously 
described for the study procedures. 
1.28.4 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an adverse event or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical 
care, or upon review by a study monitor. 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case 
report form (CRF). Information to be collected includes event description, time of onset, 
clinician’s assessment of severity, relationship to study procedures (assessed only by those with 
the training and authority to make a diagnosis), and time of resolution/stabilization of the event. 
All AEs occurring while on study will be documented appropriately regardless of relationship. 
All AEs will be followed to adequate resolution. 
Any medical or psychiatric condition that is present at the time that the participant is screened 
will be considered as baseline and not reported as an AE. However, if the study participant’s 
condition deteriorates at any time during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. Documentation of onset and duration of each 
episode will be maintained for AEs characterized as intermittent. 
The research coordinator will record events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs 
since the last visit. Events will be followed for outcome information until resolution or 
stabilization. 

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1.28.5 Adverse Event Reporting  
In consultation with the PI, a trained member of the study team will be responsible for 
conducting an evaluation of all adverse events and shall report the results of such evaluation to 
the NIH Institutional Review Board (IRB) as per Policy 801. 
1.28.6 Serious Adverse Event Reporting  
In consultation with the PI, a trained member of the study team will be responsible for 
conducting an evaluation of a serious adverse event and shall report the results of such 
evaluation to the Sponsor and the NIH Institutional Review Board (IRB) as per Policy 801. 
1.28.7 Events of Special Interest  
N/A.  
1.28.8 Reporting of Pregnancy  
N/A. 
1.29 UNANTICIPATED PROBLEMS 
1.29.1 Definition of Unanticipated Problems  
Any incident, experience, or outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; and 
• Related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
• Suggests that the research places participants or others (which many include research 
staff, family members or other individuals not directly participating in the research) at a 
greater risk of harm (including physical, psychological, economic, or social harm) than 
was previously known or expected. 
1.29.2  Unanticipated Problem Reporting  
The investigator will report unanticipated problems (UPs) to the NIH Institutional Review Board 
(IRB) as per Policy 801. 
STATISTICAL CONSIDERATIONS 
1.30 STATISTICAL HYPOTHESIS 
• Primary Endpoint Hypothesis: We will be able to transmit waveform data corresponding 
to each breathing exercise from the wearable motion sensor to the secure NIH database. 
• Secondary Endpoint Hypothesis: Chest wall motion harnessed by a wearable motion 
sensor can be accurately converted to volume of inspiration.  
1.31 SAMPLE SIZE DETERMINATION 
We hope to recruit approximately 30 participants for initial proof-of-concept data collection. 

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1.32 POPULATIONS FOR ANALYSES 
All participants will be analyzed via a per-protocol analysis. This method defines a subset of the 
participants in the full analysis (ITT) set who complied with the protocol sufficiently to ensure 
that these data would be likely to a) result in accurate models to predict post-operative outcomes, 
and b) represent the effects of the wearable on post-operative outcomes. 
1.33 STATISTICAL ANALYSES 
1.33.1 General Approach 
Data will be transmitted from the motion sensors to a secure NIH server for storage. Motion data 
will be quality checked and corrupted waveforms will be removed. Waveforms corresponding to 
activity (motion artifacts) will also be removed, per standard signal processing techniques. The 
waveforms will then be parsed out by corresponding volume of inspiration. A customized model 
will be fine-tuned on these sequences, learning to recognize patterns in chest wall motion 
associated with each incentive lung volume. To ensure that the model is unbiased, class 
balancing will be performed for both demographic and clinical labels using majority under-
sampling techniques. The transformer model will be fine-tuned and validated on the subjects in 
the dataset. Once the model is fully developed from the data collected in this study, we will test it 
against the traditional incentive spirometry to calculate its accuracy. 
1.33.2 Analysis of the Primary Endpoints 
Primary Endpoint: A database of motion waveforms corresponding to each measured volume of 
inspiration via traditional incentive spirometer.  
This endpoint will be deemed successfully completed once the data has been transmitted from 
the motion sensor to the secure NIH server for all participants. The primary goal of this study is 
to collect waveform data to correlate changes in chest wall motion with volume of inspiration. 
The first step in doing so is creation of a database with this information. All motion data will be 
quality checked and corrupted waveforms will be removed. Waveforms corresponding to activity 
will also be removed, per standard signal processing techniques.  
1.33.3 Analysis of the Secondary Endpoint(s) 
Secondary Endpoint: A cross-validated algorithm that converts chest wall motion to volume of 
inspiration. 
Motion waveforms will be annotated by volume of inspiration. A model will be fine-tuned on 
these sequences, learning to recognize subtle deteriorations in the waveform that correspond with 
varying volumes of inspiration. The pre-trained AI models will be validated for each task (e.g., 
each measured volume of inspiration). This will be done using a validation set and then test 
using a held-out test set wherein no parameter optimization is performed. Different validation 
and test sets will be generated using a cross-validation strategy such as stratified K-fold. 
 
1.33.4 Safety Analyses 
N/A. 

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1.33.5 Sub-Group Analyses 
Results will be analyzed as a whole and then based on sex and BMI to determine if these factors 
significantly impact chest wall motion corresponding to teach volume of inspiration. 
1.33.6 Tabulation of individual Participant Data 
De-identified participant data will be listed by measure and time point within our secure 
database; however, all data will be analyzed and presented as a group for further presentation or 
publication. 
1.33.7 Exploratory Analyses 
N/A. 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
1.34 INFORMED CONSENT PROCESS 
1.34.1 Consent Procedures and Documentation 
Informed consent will be obtained at the start of the investigational appointment (10-30 minutes 
in length) with the principal investigator, or an associate investigator listed on the protocol. This 
meeting will take place in a quiet, private patient room with a closed door with only relevant 
parties present. The risks and benefits of the procedure and the study will be discussed with the 
participant. Ample time will be given for the participant to ask questions, and all questions will 
be completely answered by the principal investigator or the associate investigator during the 
consent process. Once informed consent is obtained, the form will be labeled with a unique study 
identification number. This unique ID will be used to make all further data collection de-
identified. The consent forms will be sent to the NIH Health Information Management 
Department who will make it available in a digital form in the CRIS electronic medical record. 
1.34.2 Consent Process by Telephone/NIH-Approved Telehealth Platform/iMED 
Informed consent will be obtained per the Clinical Center Policy and Communication Bulletin 
MAS policy M20-1 and IRB Policy 303. Subjects will be provided a copy of the consent for 
review. Subjects will be given ample time to read and review the consent before the appointment 
for the formal informed consent process and signing. Subjects will choose the location for the 
telephone/telehealth informed consent process, but the research team will highly encourage the 
subjects to choose a location that will private, quiet, and have the remote possibility of 
interruptions. Subjects will be contacted either by telephone or NIH-approved telehealth platform 
and the non-investigational nature of this trial, the associated assessment and test options, 
biological sample collection, and attendant risks and discomforts will be carefully explained to 
the subject. 
The subject will sign and date either the paper informed consent or use electronic signature (e- 
sign) using the CC approved platform or method (iMED). 
If electronic signatures will be used, the study team plans to use the CC approved platform, 
currently iMED consent, to obtain electronic signatures. The identity of participants will be 
verified by asking them to state their full name and date of birth. The electronic signatures will 
be obtained “synchronously and in real-time” whether it is in-person, telephone, or telehealth 
consent. iMED consent will capture electronic signatures via the methods listed below: 

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• Using a smartphone: participants will be registering their signatures using their finger. 
Participants will receive a secure link that leads them to secure “web pages” that will 
capture their electronic signatures using their finger. 
• Using a computer/tablet/laptop: participants will be registering their signatures using a 
computer mouse or their finger/stylus (for touch/stylus enabled tablets and computer 
screens). Participants will receive a secure link that leads them to secure “web pages” that 
will capture their electronic signatures using the aforementioned methods. 
Signed paper copies of consent will be returned via fax, mail, or secure e-mail to the consenting 
investigator to be signed and dated. A fully executed copy of the consent will be available in the 
participant’s research record. Consent forms signed using the CC approved electronic signature 
platform (iMED consent) will be archived and stored in the participant’s research record via an 
automatic secure electronic transmission immediately after all the required signatures are obtained. 
All participants will be provided with a copy of the fully executed consent (paper copy by mail or 
electronic copy by secure electronic methods based on participant’s preference). The informed 
consent process will be documented in the medical record, including the name of the interpreter. 
1.34.3 Considerations for Consent of NIH staff, or family members of study team members 
Consent for NIH staff will be obtained as detailed above with following additional protections: 
Consent from staff members will be obtained by an individual independent of the staff member’s 
team whenever possible. If a staff member participates in the study, consent will not be obtained 
by the principal investigator or any direct superior on the research team. Otherwise, the consent 
procedure will be monitored by the CC Department of Bioethics Consultation Service in order to 
minimize the risk of undue pressure on the staff member. 
The NIH Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in 
NIH Research will be made available. 
1.34.4 Consent of Subjects who Are, Or Become, Decisionally Impaired 
Adults unable to provide consent are excluded from enrolling in the protocol. Given the short 
study duration (10-20 minutes), it is highly unlikely that participants would lose capacity to 
provide consent within the duration of the study.  
1.35 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
investigator, and regulatory authorities. If the study is prematurely terminated or suspended, the 
Principal Investigator will promptly inform study participants, the Institutional Review Board 
(IRB), and sponsor and will provide the reason(s) for the termination or suspension. Study 
participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 

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• Determination that the primary endpoint has been met 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the IRB. 
1.36 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s). This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, representatives of the Institutional Review Board (IRB), and/or regulatory 
agencies may inspect all documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) and pharmacy records 
for the participants in this study. The clinical study site will permit access to such records. 
The study participant’s data will be securely stored for internal use and analysis during the study. 
At the end of the study, all records will continue to be saved digitally in the DRD shared drive 
managed by DCRI for as long a period as dictated by the reviewing IRB, Institutional policies, or 
sponsor requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at a secure NIH server within the NIH Clinical Center 
building. This will not include the participant’s contact or identifying information. Rather, 
individual participants and their research data will be identified by a unique study identification 
number. The study data entry and study management systems used by clinical sites and by 
clinical center research staff will be secured and password protected. At the end of the study, all 
study databases will be de-identified and archived on a secure NIH server. 
To further protect the privacy of study participants, a Certificate of Confidentiality has been 
issued by the National Institutes of Health (NIH). This certificate protects identifiable research 
information from forced disclosure. It allows the investigator and others who have access to 
research records to refuse to disclose identifying information on research participation in any 
civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or 
local level. By protecting researchers and institutions from being compelled to disclose 
information that would identify research participants, Certificates of Confidentiality help achieve 
the research objectives and promote participation in studies by helping assure confidentiality and 
privacy to participants. 
1.36.1 Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data 
Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be 
made available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure 
all mechanisms used to share data will include proper plans and safeguards for the protection of 
privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be 

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thoroughly de-identified and will not be traceable to a specific study participant). Plans for 
archiving and long-term preservation of the data will be implemented, as appropriate.  
1.36.2 Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services 
(HHS), has issued a Certificate of Confidentiality (CoC) to all researchers engaged in 
biomedical, behavioral, clinical or other human subjects research funded wholly or in part by the 
federal government. Recipients of NIH funding for human subjects research are required to 
protect identifiable research information from forced disclosure per the terms of the NIH Policy 
(see https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 
75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered by 
this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the protocol is managed in compliance with 
Federal statutes, and regulations. It is the NIH policy that investigators and others who have 
access to research records will not disclose identifying information except when the participant 
consents or in certain instances when federal, state, or local law or regulation requires disclosure. 
NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
1.37 FUTURE USE OF STORED SPECIMENS AND DATA 
We do not intend to store any specimens for this protocol. All motion data will be stored through 
a secure NIH server located in the NIH Clinical Center. 
1.38 SAFETY OVERSIGHT 
Safety oversight will be performed through the NIH Clinical Center’s Quality Assurance 
Program. The clinical research team will meet on a regular basis (approximately weekly) when 
subjects are being actively enrolled/evaluated on the study to discuss data analysis or operational 
issues.  
All data will be collected in a timely manner and reviewed by the principal investigator or a lead 
associate investigator. Events meeting requirements for expedited reporting as described in 
HRPP Policy 801 will be submitted within the required timelines.  
The principal investigator will review all data on each subject to ensure safety and data accuracy. 
The principal investigator will personally conduct or supervise the investigation and provide 
appropriate delegation of responsibilities to other members of the research staff. 
1.39 CLINICAL MONITORING 
Accrual and safety data will be monitored by the principal investigator, who will provide 
oversight to the conduct of this study. The PI will continuously evaluate implementation of the 
protocol for any unusual or unpredicted complications that occur and will review the data for 
accuracy and completeness. The principal investigator will review adverse event and response 
data on each patient to ensure safety and data accuracy. The principal investigator will personally 
conduct or supervise the investigation and provide appropriate delegation of responsibilities to 
other members of the research staff. 

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1.40 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data and biological 
specimen collection, documentation and completion. An individualized quality management plan 
will be developed to describe a site’s quality management. The device will only have contact 
with the skin via the adhesive and will not be exposed to any bodily fluids. The casing is 
“indoor/outdoor, waterproof, dustproof, anti-UV and vibration resistant. It will be sanitized with 
a hydrogen peroxide cleaner disinfectant wipe between each use. 
Quality control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/resolution. 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the 
clinical trial is conducted, and data are generated and biological specimens are collected, 
documented (recorded), and reported in compliance with the protocol, International Council on 
Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory requirements (e.g., 
Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).  
The investigational site will provide direct access to all study related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the IC, and inspection 
by local and regulatory authorities. 
1.41 DATA HANDLING AND RECORD KEEPING  
1.41.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the assigned study coordinator under the supervision of 
the principal investigator. The investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
All data in this study will be collected and stored digitally. Data will be entered into an Excel 
spreadsheet on the research NIH-owned computer during and after each procedure. The data will 
be transferred to a secure server in the DRD shared drive that is password protected and 
compliant with the data collection policies of the NIH Clinical Center and federal regulations for 
storage, analysis and archiving. All relevant data from the patient chart will also be entered on an 
encrypted private computer database from which formal analyses are done, according to NIH and 
Clinical Center policy. The secure central data base will be maintained by the data base manager 
on a secure password protected computer with secure Clinical Center network backup, in 
accordance with NIH CC policy. The data system includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate. The responsible investigators are Peter Pinto, MD. 
1.41.2 Study Records Retention 
Study documents should be retained as per the NIH Intramural Records Retention Schedule. No 
records will be destroyed without the written consent of the sponsor, if applicable. 
1.42 PROTOCOL DEVIATIONS AND NON-COMPLIANCE 
It is the responsibility of the investigator to use continuous vigilance to identify and report 
deviations to the NIH Institutional Review Board as per Policy 801. All deviations must be 

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addressed in study source documents, reported to Clinical Center Program Official. The 
investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
1.42.1.1 NIH Definition of Protocol Deviation 
A protocol deviation is any changed, divergence, or departure from the IRB-approved research 
protocol.  
• Major deviations: Deviations from the IRB approved protocol that have, or may have the 
potential to, negatively impact the rights, welfare or safety of the subject, or to 
substantially negatively impact the scientific integrity or validity of the study. 
• Minor deviations: Deviations that do not have the potential to negatively impact the 
rights, safety or welfare of subjects or others, or the scientific integrity or validity of the 
study. 
1.43  HUMAN DATA SHARING AND PUBLICATION 
This study will comply with the NIH Data Management and Sharing (DMS) Policy, which 
applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is 
associated with a ZIA, with a clinical protocol that undergoes scientific review.  
1.43.1  NIH Public Access Policy Compliance 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. It requires scientists to submit final peer-
reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central 
upon acceptance for publication.  
ABBREVIATIONS 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DSMB 
Data Safety Monitoring Board 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS Genome-Wide Association Studies 
ICH 
International Council on Harmonisation  
ICMJE International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
IS 
Incentive Spirometry 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
NIH  
National Institutes of Health 
NIH IC NIH Institute or Center 
OHRP 
Office for Human Research Protections 

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PI 
Principal Investigator 
PII 
Personally Identifiable Information 
PPC 
Postoperative Pulmonary Complications 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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