Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
Phase: NA
Conditions: Hypotension, Hypertension
Sponsor: NYU Langone Health

 
 
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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as author-
ized in writing by the study sponsor 
Interventional Template Version: 28 APR 2017 
 
 
 
Tool Revision History: 
 
Version Number 
Version Date 
Summary of Revisions Made 
1.0 
21 Mar 2018 
Original version 
2.0 
15 Mar 2019 
Version 2 
3.0 
18 July 2019 
Version 3 – Inclusion to NYU Langone Neurocritical Intensive 
Care Unit 
 
ACCURACY OF NON-INVASIVE NON-OSCILLOMETRIC BLOOD PRES-
SURE WRISTBAND 
 
A single-center study of the accuracy of a non-invasive, non-oscillometric blood pressure wristband when 
compared with an intra-arterial blood pressure catheter 
 
 
Principal Investigator: 
Greta L. Piper, MD 
Department of Surgery 
550 First Ave, Suite 7V 
New York, NY 10016 
Greta.piper@nyumc.org 
212-263-8890 
Additional Investigators: 
Patricia Ayoung-Chee, MD 
Department of Surgery 
550 First Ave, HCC 6C 
New York, NY 10016 
Patricia.ayoung-chee@nyumc.org 
212-263-8890 
NYULMC Study Number: 
17-00884  
Funding Sponsor: 
LiveMetric 
IND/IDE Number:  
IDE Exempt 
Regulatory Sponsor:  
N/A 
Study Product: 
LiveMetric Blood Pressure Wristband 
Study Product Provider:  
LiveMetric 
ClinicalTrials.gov Number  NCT03629535  
 
 
Initial version: 08/01/2017 
Amended: 
03/15/2019 
Amended: 
07/18/2019 

 
 
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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as author-
ized in writing by the study sponsor 
Interventional Template Version: 28 APR 2017 
 
 

Study number: 17-00884 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. 
The Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 
 

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Table of Contents 
 
STATEMENT OF COMPLIANCE ............................................................................................................ 3 
LIST OF ABBREVIATIONS ..................................................................................................................... 5 
PROTOCOL SUMMARY ......................................................................................................................... 1 
SCHEMATIC OF STUDY DESIGN .......................................................................................................... 3 
1. 
KEY ROLES ............................................................................................................................ 4 
2. 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ............... 4 
2.1. 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ............................................................. 4 
2.2. 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL AGENT ............................................................ 4 
2.3. 
POTENTIAL RISKS & BENEFITS .................................................................................................... 5 
2.3.1. 
Known Potential Risks ........................................................................................................ 5 
2.3.2. 
Known Potential Benefits .................................................................................................... 5 
3. 
OBJECTIVES AND PURPOSE ................................................................................................ 5 
3.1. 
PRIMARY OBJECTIVE ................................................................................................................. 5 
3.2. 
SECONDARY OBJECTIVES (IF APPLICABLE) ................................................................................... 5 
4. 
STUDY DESIGN AND ENDPOINTS ......................................................................................... 5 
4.1. 
DESCRIPTION OF STUDY DESIGN ................................................................................................ 5 
4.2. 
STUDY ENDPOINTS .................................................................................................................... 6 
4.2.1. 
Primary Study Endpoints ..................................................................................................... 6 
5. 
STUDY ENROLLMENT AND WITHDRAWAL .......................................................................... 6 
5.1. 
INCLUSION CRITERIA ................................................................................................................. 6 
5.2. 
EXCLUSION CRITERIA ................................................................................................................ 6 
5.3. 
VULNERABLE SUBJECTS ............................................................................................................ 6 
5.4. 
STRATEGIES FOR RECRUITMENT AND RETENTION ......................................................................... 7 
5.4.1. 
Use of DataCore/Epic Information for Recruitment Purposes ............................................... 7 
5.5. 
DURATION OF STUDY PARTICIPATION .......................................................................................... 7 
5.6. 
TOTAL NUMBER OF PARTICIPANTS AND SITES .............................................................................. 7 
5.7. 
PARTICIPANT WITHDRAWAL OR TERMINATION............................................................................... 7 
5.7.1. 
Reasons for Withdrawal or Termination ............................................................................... 7 
5.7.2. 
Handling of Participant Withdrawals or Termination ............................................................. 7 
5.8. 
PREMATURE TERMINATION OR SUSPENSION OF STUDY ................................................................. 7 
6. 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE ETC.) AND/OR 
PROCEDURAL INTERVENTION ............................................................................................................ 8 
6.1. 
STUDY AGENT(S) AND CONTROL DESCRIPTION ............................................................................ 8 
6.1.1. 
Acquisition .......................................................................................................................... 8 
6.1.2. 
Device Specific Considerations ........................................................................................... 8 
6.1.4. 
Administration of Intervention .............................................................................................. 8 
6.1.5. 
Assessment of Subject Compliance with Study Intervention ................................................ 8 
6.2. 
STUDY PROCEDURES/EVALUATIONS ........................................................................................... 8 
6.2.1. 
Study Specific Procedures .................................................................................................. 8 
6.2.2. 
Screening ........................................................................................................................... 8 
7.1. 
SPECIFICATION OF SAFETY PARAMETERS .................................................................................... 9 
7.1.1. 
Definition of Adverse Events (AE) ....................................................................................... 9 
7.1.2. 
Definition of Serious Adverse Events (SAE) ........................................................................ 9 
7.1.3. 
Definition of Unanticipated Problems (UP) ........................................................................... 9 
7.2. 
CLASSIFICATION OF AN ADVERSE EVENT ................................................................................... 10 
7.2.1. 
Severity of Event ............................................................................................................... 10 
7.2.2. 
Relationship to Study Agent .............................................................................................. 10 

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7.2.3. 
Expectedness ................................................................................................................... 10 
7.4. 
REPORTING PROCEDURES – NOTIFYING THE IRB ....................................................................... 11 
7.4.1. 
Adverse Event Reporting .................................................................................................. 11 
7.4.2. 
Serious Adverse Event Reporting...................................................................................... 11 
7.4.3. 
Unanticipated Problem Reporting ...................................................................................... 11 
7.5. 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR .................................................... 12 
7.6. 
STUDY HALTING RULES ........................................................................................................... 13 
9. 
STATISTICAL CONSIDERATIONS ....................................................................................... 13 
9.1. 
STATISTICAL AND ANALYTICAL PLANS (SAP) .............................................................................. 13 
9.2. 
STATISTICAL HYPOTHESIS ........................................................................................................ 14 
9.2.1. 
General Approach ............................................................................................................. 14 
9.2.2. 
Analysis of the Primary Efficacy Endpoint(s)...................................................................... 14 
9.2.3. 
Baseline Descriptive Statistics........................................................................................... 14 
9.2.4. 
Planned Interim Analysis ................................................................................................... 14 
9.5. 
SAMPLE SIZE .......................................................................................................................... 16 
9.6. 
MEASURES TO MINIMIZE BIAS ................................................................................................... 16 
10. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ......................... 16 
11. 
QUALITY ASSURANCE AND QUALITY CONTROL ............................................................. 16 
12. 
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................................... 17 
12.1. 
ETHICAL STANDARD ................................................................................................................ 17 
12.2. 
INSTITUTIONAL REVIEW BOARD ................................................................................................. 17 
12.3. 
INFORMED CONSENT PROCESS ................................................................................................ 17 
12.3.1. 
Consent/Assent and Other Informational Documents Provided to Participants ................... 17 
12.3.2. 
Consent Procedures and Documentation .......................................................................... 17 
12.4. 
PARTICIPANT AND DATA CONFIDENTIALITY ................................................................................. 18 
13. 
DATA HANDLING AND RECORD KEEPING ........................................................................ 18 
13.1. 
STUDY RECORDS RETENTION ................................................................................................... 18 
13.2. 
PROTOCOL DEVIATIONS ........................................................................................................... 18 
13.4. 
PUBLICATION AND DATA SHARING POLICY ................................................................................. 19 
14. 
STUDY FINANCES ................................................................................................................ 19 
14.1. 
FUNDING SOURCE ................................................................................................................... 19 
14.2. 
COSTS TO THE PARTICIPANT .................................................................................................... 19 
14.3. 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ......................................................................... 19 
15. 
STUDY ADMINISTRATION .................................................................................................... 20 
THIS STUDY INCLUDES ONLY THE INVESTIGATORS LISTED IN PRIOR SECTIONS. ................................................ 20 
16. 
CONFLICT OF INTEREST POLICY ....................................................................................... 20 
17. 
REFERENCES ....................................................................................................................... 21 
18. 
ATTACHMENTS .................................................................................................................... 22 
 
 
 
 
 
List of Abbreviations 
 
 
AE 
Adverse Event/Adverse Experience 

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CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CSOC 
Clinical Study Oversight Committee 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 
 
 
 
 

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Protocol Summary 
Title 
Accuracy of non-invasive, non-oscillometric blood pressure wristband 
Short Title 
Non-invasive blood pressure wristband accuracy 
Brief Summary 
In an intensive care unit patients who already have an intra-arterial blood pres-
sure monitor in place, this wristband device will be applied and blood pressure 
readings compared for approximately 30 minutes. Blood pressure readings will 
be gathered and compared. 
Phase 
N/A 
Objectives 
The primary objective of the present investigation is to determine the accuracy 
of a non-invasive non-oscillometric blood pressure wristband device when 
compared to invasive intra-arterial blood pressure monitors. 
Methodology 
Open, single arm, pilot study 
Endpoint 
The percentage of blood pressure measurements falling within the acceptable 
standard deviation will be compared. 
Study Duration 
Total study duration is expected to be 1 month. 
Participant Duration 
Participant involvement duration is expected to be approximately 30 minutes. 
Duration of IP admin-
istration 
Total duration of investigational device use is 30 minutes. 
Population 
Patients admitted to the Intensive Care Unit who are already fitted with an in-
vasive Arterial Line (A Line) are eligible for the trial, and no volunteer candi-
dates for an A Line are requested. Sample size is expected to be approxi-
mately 15 patients. 
Study Sites 
NYU Langone Health Surgical Intensive Care Unit, Cardiovascular Intensive 
Care Unit, Neurologic Intensive Care Unitand NYU Langone Brooklyn Surgical 
Intensive Care Unit and Neurologic Intensive Care Unit 
Number of participants 
Total sample size is expected to be 15 patients. 
Description of Study 
Agent/Procedure 
The device is a band intended to be worn on the wrist for intermittent blood 
pressure measurements. The device applies no inflatable mechanics or mov-
ing parts. The wristband is watertight and can be worn as any type of bracelet. 
Reference Therapy 
The investigational wristband is being compared to an intra-arterial blood pres-
sure monitor. 
Key Procedures 
Wristband application for 30 minutes. 
Statistical Analysis 
For each of the subjects, 10 intra-arterial blood pressure measurements will 
be collected and 10 wristband measurements will be collected at the same 
time points. 

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Systolic and diastolic blood pressure measurements will be compared using 
an acceptable standard deviation of 10 mm Hg (+/-5 mm Hg). 
Mean arterial pressure measurements will be compared using an acceptable 
standard deviation of 5 mm Hg (+/- 2.5 mm Hg). 
 
The percentage of blood pressure measurements falling within the acceptable 
standard deviation will be compared. 
The percentage of blood pressure measurements for each patient falling 
within the acceptable standard deviation will also be compared. 
 
 
 
 
 
 

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Schematic of Study Design 
 
1. Patients in the ICU with an intra-arterial blood pressure monitor already in place will be considered 
as subjects. 
2. Verbal consent to participate will be obtained. 
3. The blood pressure wristband will be applied to one wrist to allow for blood pressure measurements 
to be obtained and recorded. The blood pressure wristband will then be applied to the contralateral 
wrist for measurements. The total time of device application is expected to be approximately 30 
minutes. 
4. Demographics of the subject will be anonymous collected – height, weight, age, current medica-
tions, and general condition. 
5. Blood pressure measurements from both the wristband and the intra-arterial blood pressure moni-
tor will be compared. 
 
 
 
 

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1. Key Roles 
 
Greta L. Piper, MD, Principal Investigator 
NYU School of Medicine 
550 First Ave, Suite 7 V, New York, NY 10016 
212-263-8890 
Greta.piper@nyumc.org 
 
Patricia Ayoung-Chee, MD, Co-Investigator 
NYU School of Medicine 
550 First Avenue, New York, NY 10016 
212-263-8890 
Patricia.ayoung-chee@nyumc.org 
 
 
2. Introduction, Background Information and Scientific Rationale 
 
2.1. Background Information and Relevant Literature 
Hypertension is a common medical condition that increases the risk of ischemic heart disease, stroke, pe-
ripheral vascular disease, and other cardiovascular diseases. Currently the gold standard for blood pres-
sure management is an invasive intra-arterial blood pressure monitor. 
 
A noninvasive wristband device has been developed for measurement of intermittent blood pressure. It is 
intended to be work in day-to-day life by people with hypertension or other conditions where blood pres-
sure monitoring is important. 
 
The purpose of this study is to determine the accuracy of the non-invasive wristband device when com-
pared to the invasive gold standard. 
 
Lehman LW, Saeed M, Talmor D, Mark R, Malhotra A. Methods of blood pressure measurement in the 
ICU. Crit Care Med. 2013;41:34–40. doi: 10.1097/CCM.0b013e318265ea46. 
2.2. Name and Description of the Investigational Agent  
LiveMetric has developed a wristband device for measurement of intermittent blood pressure. It does not 
require any action by the user other than wearing the band on the wrist. The device uses no inflatable 
mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. See at-
tachment for device image. 
 
The wristband device meets the criteria for IDE exemption because it is a diagnostic device that:  
(i) Is noninvasive,  
(ii) Does not require an invasive sampling procedure that presents significant risk,  
(iii) Does not by design or intention introduce energy into a subject, and  
(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically es-
tablished diagnostic product or procedure.  
 

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2.3. Potential Risks & Benefits 
2.3.1. Known Potential Risks 
The only potential risk is the possible discomfort associated with wearing the wristband device. 
2.3.2. Known Potential Benefits 
There is no potential benefit to participating in this study. In the future, the device may be used to benefit 
patients with high blood pressure or other conditions in which blood pressure monitoring is important. 
 
3. Objectives and Purpose 
3.1. Primary Objective 
The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscil-
lometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors 
within the ISO-81060-2 requirements 
3.2. Secondary Objectives (if applicable) 
N/A 
4. Study Design and Endpoints 
4.1. Description of Study Design 
 
1. A medical professional will measure simultaneous non-invasive auscultatory readings to determine 
the lateral difference for later adjustment of calculation accordingly. Calculation of lateral difference 
is provided in section (Error! Reference source not found.). All data from a subject shall be ex-
cluded if: i) the lateral difference of the reference systolic BP readings is more than 15 mmHg (2,00 
kPa); or ii) the lateral difference of the reference diastolic BP readings is more than 10 mmHg (1,33 
kPa).  
2. If subject's reading is eligible, the medical professional or research personnel will place the Live-
Metric wristband on the opposite limb than the one having the A-line, providing the location of the 
placement has intact skin.  
3. During the measurement stage, BP values are simultaneously recorded from the reference invasive 
A-line and the LiveMetric device. In addition, other vital signs from the monitoring equipment can 
be collected as available (ECG, Respiratory rate, Pleth, and HR). The invasive BP values and other 
vital signs are captured from the Vital Signs Monitor (available in the patient’s room) and the 
LiveMetric device. A measurement session of 30 minutes will be conducted for each subject.  Dur-
ing the measurements, no information from the device will be provided to the investigator or study 
personnel.  All the data will be processed and analyzed post-measurement according to the follow-
ing considerations as required by the standard: only up to 10 consecutive measurements per sub-
ject will be analyzed; measurement will be made over 30 seconds of recording; consecutive meas-

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urement will be considered as the next 30 seconds following at least a 60 second interval. Meas-
urement (data points) is defined as recording or acquisition of signal from the monitor. The medical 
professional will take off the wristband at the end of this process. 
4. All measurements will be processed and analyzed retrospectively according to the requirements of 
the standard (ISO 81060-2) as detailed below in section (Error! Reference source not found.). A 
30-minute session of measurements will be conducted for each subject.  All the data will be pro-
cessed and analyzed post measurement according to the following considerations as required by 
the standard; only up to 10 consecutive measurements per subject will be analyzed; measurement 
will be made over 30 seconds of recording; consecutive measurement will be considered as the 
next 30 seconds following at least a 60 second interval.   
5. All data points recoded during the first phase will be sent for processing and calibrating the algo-
rithm. All the data points recorded during the second stage will be post processed by algorithm and 
results will be analyzed by an unbiased third party (bio-statistician).  
6. Demographics of the subject will be anonymous collected from the electronic medical record – 
height, weight, age, current medications, and general condition. 
7. Blood pressure measurements from both the wristband and the intra-arterial blood pressure moni-
tor will be compared. 
 
4.2. Study Endpoints 
4.2.1. Primary Study Endpoints 
 
The study endpoint will be the time when 10 blood pressure measurements have been obtained from a 
subject wearing the wristband. 
5. Study Enrollment and Withdrawal 
 
5.1. Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Adult (>18 years old) ICU patient who already has an intra-arterial blood pressure measurement 
in place. 
 
5.2. Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Body habitus that precludes patients from wearing a device on their wrist 
2. Subjects without normal palpable radial artery pulse, whether congenital, due to medical interven-
tion, or otherwise  
3. Subjects with wrist circumference less than 155mm or greater than 210mm 
4. Subjects implanted with VAD’s or other mechanical circulatory support device whether intracorpo-
real or extracorporeal 
5. Patients that do not have an intra-arterial blood pressure line. 
 
 
 

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5.3. Vulnerable Subjects 
No vulnerable subjects will be included in this study. Given the population at the SICU, it is possible that 
some patients might not have capacity to consent for themselves. Each potential subject with be as-
sessed for their capacity to provide consent. Patients who are not alert, oriented, and able to comprehend 
the study will not be asked to participate in this study. Only those with capacity to consent for themselves 
will be enrolled. 
5.4. Strategies for Recruitment and Retention 
Target sample size is 15 patients. The anticipated number of patients to be screened in order to reach the 
target enrollment is 20 patients. 
Only adult patients admitted to theNYU Langone Health Surgical ICU, Cardiovascular ICU, Neurologic 
ICU and NYU Langone Brooklyn Surgical ICU and Neurologic ICU will be considered. Participation is vol-
untary and will require verbal consent. Volunteers who do not already have an intra-arterial catheter in 
place will not be considered. 
5.4.1. Use of DataCore/Epic Information for Recruitment Purposes 
Potential subjects will be identified using the daily NYU Langone Health ICU and NYU Langone Brooklyn 
ICU census. The study investigators have a clinical relationship with these patients and will approach them 
for participation. 
No DataCore/Epic information will be used for recruitment. 
 
5.5. Duration of Study Participation 
The total duration of subject participation in the study is expected to be approximately 30 minutes. 
5.6. Total Number of Participants and Sites  
 
Recruitment will end when approximately 20 participants are enrolled. It is expected that approximately 
20 participants will be enrolled in order to produce 15 evaluable participants. 
 
5.7. Participant Withdrawal or Termination 
5.7.1. Reasons for Withdrawal or Termination 
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the partic-
ipant 
• 
The participant meets an exclusion criterion (either newly developed or not previously recog-
nized) that precludes further study participation 
 
5.7.2. Handling of Participant Withdrawals or Termination 
A subject may withdraw from the study at any time. If a subject withdraws, his or her data will not be in-
cluded in this analysis. An additional subject will be needed to allow for the goal sample size to be 
achieved. 
 
5.8. Premature Termination or Suspension of Study 
 
 

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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 the investigators. If the study is prematurely terminated or sus-
pended, the PI will promptly inform the IRB and will provide the reason(s) for the termination or suspen-
sion. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and sat-
isfy the sponsor, IRB and/or FDA. 
 
6. Study Agent (Study drug, device, biologic, vaccine etc.) and/or 
Procedural Intervention  
6.1. Study Agent(s) and Control Description 
The device is a wristband. Because the subjects also have an intra-arterial blood pressure monitor in 
place, the subjects will serve as their own control. 
6.1.1. Acquisition 
LiveMetric will provide the blood pressure wristbands for use in this study. 
 
6.1.2. Device Specific Considerations 
The device is a wristband that will be worn by the subject for approximately 30 minutes. See the attached 
image for further details. The BP data will be downloaded to a laptop using Medicollector software. No pa-
tient information is included only the BP signals. 
 
6.1.4. Administration of Intervention 
The wristband device will be applied by an investigator. It will be removed by an investigator at the end of 
the study period. 
 
6.1.5. Assessment of Subject Compliance with Study Intervention 
The subject will be directly observed by an investigator when wearing the investigational wristband to en-
sure compliance. 
 
6.2. Study Procedures/Evaluations 
Blood pressure measurements from the arterial line will be recorded directly from the intra-arterial 
blood pressure monitor screen. Blood pressure measurements from the wristband device will be 
downloaded to a laptop computer using Medicollector software. No patient information will be in-
cluded. 
6.2.1. Study Specific Procedures 
 
The following information will be collected anonymously for each subject: Age, weight, current  
 
inpatient medications, general condition. No PHI will be saved. 
 
 

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6.2.2. Screening  
Once a patient has been admitted to the NYU Langone Health Hospital, Surgical ICU, Cardiovascular 
ICU, or Neurologic ICU or NYU Langone Brooklyn Surgical ICU or Neurologic ICU, and an intra-arterial 
blood pressure monitor has been placed, an investigator will approach the subject to determine willing-
ness to participate in the study and to obtain verbal consent. 
7. Assessment of Safety 
 
7.1. Specification of Safety Parameters  
No specific safety parameters. The only anticipated risk is the potential discomfort associated with wear-
ing the wristband device. 
7.1.1. Definition of Adverse Events (AE) 
 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
7.1.2. Definition of Serious Adverse Events (SAE) 
 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance. They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above. For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious ad-
verse events.  
 
7.1.3. Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency  (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 

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• Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the pro-
cedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
 
This definition could include an unanticipated adverse device effect, any serious adverse effect on health 
or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the investiga-
tional plan or application (including a supplementary plan or application), or any other unanticipated seri-
ous problem associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 
812.3(s)). 
 
7.2. Classification of an Adverse Event 
7.2.1. Severity of Event 
 
For AEs not included in the protocol defined grading system, the following guidelines will be used to de-
scribe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s daily ac-
tivities. 
• 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 ther-
apy or other treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
7.2.2. Relationship to Study Agent 
 
The clinician’s assessment of an AE's relationship to study agent (drug, biologic, device) is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. If there 
is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs must 
have their relationship to study agent assessed. In a clinical trial, the study product must always be sus-
pect. To help assess, the following guidelines are used. 
 
• Related – The AE is known to occur with the study agent, there is a reasonable possibility that the 
study agent caused the AE, or there is a temporal relationship between the study agent and event. 
Reasonable possibility means that there is evidence to suggest a causal relationship between the 
study agent and the AE. 
• Not Related – There is not a reasonable possibility that the administration of the study agent 
caused the event, there is no temporal relationship between the study agent and event onset, or 
an alternate etiology has been established. 
 
 
7.2.3. Expectedness 
The only expected potential risk is the possible discomfort associated with wearing the wristband. No 
other adverse events are expected. 
 
 
7.3. Time Period and Frequency for Event Assessment and Follow-Up 
 

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The occurrence of an AE or SAE may come to the attention of study personnel during study visits and in-
terviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs in-
cluding local and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate 
RF. Information to be collected includes event description, time of onset, clinician’s assessment of sever-
ity, relationship to study product (assessed only by those with the training and authority to make a diagno-
sis), and time of resolution/stabilization of the event. All AEs occurring while on study must be docu-
mented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical 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. UPs will be recorded in the data collection system through-
out the study. 
 
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. AEs characterized as intermittent require documentation of on-
set and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is ob-
tained 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.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the sub-
ject’s personal physician, believes might reasonably be related to participation in this study.  The investi-
gator should notify the study sponsor of any death or adverse event occurring at any time after a subject 
has discontinued or terminated study participation that may reasonably be related to this study.  The 
sponsor should also be notified if the investigator should become aware of the development of cancer or 
of a congenital anomaly in a subsequently conceived offspring of a subject that has participated in this 
study.  
 
7.4. Reporting Procedures – Notifying the IRB  
 
7.4.1. Adverse Event Reporting 
Adverse events will be reported to the investigators, the involved subject, the IRB, and to LiveMetric 
within 24 hours of the event. 
 
 
7.4.2. Serious Adverse Event Reporting 
Serious adverse events will be reported to the investigators, the involved subject, the IRB, and to Live-
Metric within 24 hours of the event. 
 
7.4.3. Unanticipated Problem Reporting 
 
 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP re-
port form. It is the site investigator’s responsibility to report UPs to their IRB and to the DCC/study spon-
sor. The UP report will include the following information: 
 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• A detailed description of the event, incident, experience, or outcome; 

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• An explanation of the basis for determining that the event, incident, experience, or outcome repre-
sents an UP; 
• A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
• UPs that are SAEs will be reported to the IRB and to the DCC/study sponsor within <insert time-
line in accordance with policy> of the investigator becoming aware of the event. 
• Any other UP will be reported to the IRB and to the DCC/study sponsor within <insert timeline in 
accordance with policy> of the investigator becoming aware of the problem. 
• All UPs should be reported to appropriate institutional officials (as required by an institution’s writ-
ten reporting procedures), the supporting agency head (or designee), and OHRP within<insert 
timeline in accordance with policy> of the IR’s receipt of the report of the problem from the investi-
gator. 
 
7.5. Reporting Procedures – Notifying the Study Sponsor 
 
 
The study clinician will complete a SAE Form within the following timelines: 
 
• All deaths and immediately life-threatening events, whether related or unrelated, will be recorded 
on the SAE Form and submitted to the DCC/study sponsor within 24 hours of site awareness. See 
Section 1, Key Roles for contact information. 
• Other SAEs regardless of relationship will be submitted to the DCC/study sponsor within 72 hours 
of site awareness. 
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be 
chronic or the adherence to be stable. Other supporting documentation of the event may be requested by 
the DCC/study sponsor and should be provided as soon as possible.  
 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the investigator 
shall provide further information, as applicable, on the unanticipated event or the unanticipated problem in 
the form of a written narrative.  This should include a copy of the completed Unanticipated Problem form, 
and any other diagnostic information that will assist the understanding of the event.  Significant new infor-
mation on ongoing unanticipated adverse effects shall be provided promptly to the study sponsor. 
 
 
 
The study investigator shall complete an Unanticipated Adverse Device Effect Form and submit to the 
study sponsor and to the reviewing IRB as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the effect. The study sponsor contact information is provided in Section 
1, Key Roles. 
 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the 
investigator shall provide further information, as applicable, on the unanticipated event or the 
unanticipated problem in the form of a written narrative.  This should include a copy of the com-
pleted Unanticipated Problem form, and any other diagnostic information that will assist the un-
derstanding of the event.  Significant new information on ongoing unanticipated adverse effects 
shall be provided promptly to the study sponsor. 
 
The study sponsor is responsible for conducting an evaluation of an unanticipated adverse de-
vice effect and shall report the results of such evaluation to FDA and to all reviewing IRBs and 
participating investigators within 10 working days after the sponsor first receives notice of the 

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effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA 
requests. 
 
 
7.6. Study Halting Rules 
 
If any SAE occurs, during the study, the study will be stopped. 
 
7.7. Safety Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her 
site.  This safety monitoring will include careful assessment and appropriate reporting of ad-
verse events as noted above, as well as the construction and implementation of a site data and 
safety-monitoring plan. Medical monitoring will include a regular assessment of the number and 
type of serious adverse events. 
 
 
8. 
Clinical Monitoring 
 
PI will be conducting monitoring to ensure safety of subjects. 
 
 
9. 
Statistical Considerations 
Data from the A-line monitor and from the LiveMetric device shall be collected and pro-
cessed using a validated Software. Categorical parameters shall be presented in percent-
ages and will be compared using X2 testing. Continuous variables shall be reported as 
mean  standard deviation and will be compared using the Student’s t-test. Correlation 
shall be determined via linear regression analysis. Agreement shall be determined via the 
Bland and Altman technique. The analysis shall be conducted for intermittent values by ap-
plying the reference ISO 81060-2:2013. 
The LiveMetric device shall provide values for each intermittent session and shall be com-
pared to a range measured by the A-Line (data point). The data point is defined as the interval 
between the lower and higher value read by the A-Line, providing: the interval is no less than 
30 seconds; the difference range from the reference device is less than the permissible 
highest range of 20 mmHg for SYS and 12 mmHg for DIA. Should the LiveMetric device read 
within the same range as the A-line, then the reading is considered accurate. However, if the 
reading is not within the defined range, then the error rate is defined as the range in mmHg 
between the closest edges of the reference reading to the values obtained by the LiveMetric 
device 
9.1. Statistical and Analytical Plans (SAP) 
Baseline demographics including age, weight, current medications, and general medical condi-
tion will be collected anonymously. 
 
For each of the subjects, 10 intra-arterial blood pressure measurements will be collected and 10 
wristband measurements will be collected at the same time points. 
Systolic blood pressure measurements will be compared using an acceptable standard devia-
tion of 10 mm Hg (+/-5 mm Hg). 
Diastolic blood pressure measurements will be compared using an acceptable standard devia-
tion of 10 mm Hg (+/-5 mm Hg). 

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Mean arterial pressure measurements will be compared using an acceptable standard deviation 
of 5 mm Hg (+/- 2.5 mm Hg). 
 
The percentage of blood pressure measurements falling within the acceptable standard devia-
tion will be compared. 
The percentage of blood pressure measurements for each patient falling within the acceptable 
standard deviation will also be compared. 
 
9.2. Statistical Hypothesis 
The hypothesis is that >90% of wristband blood pressure measurements will be within the ac-
cepted standard deviation when compared to the intra-arterial blood pressure measurements. 
 
9.2.1. General Approach 
All statistal analysis for this study will be performed by Dr. Patricia Ayoung-Chee, MD, MPH u-
sing Stat 15 software when needed. 
9.2.2. Analysis of the Primary Efficacy Endpoint(s) 
N/A 
9.2.3. Baseline Descriptive Statistics 
N/A 
 
9.2.4. Planned Interim Analysis 
N/A 
 
9.3.1. Determining the reference BP 
The invasive SYS and DIA BP values shall be determined from the recordings. (The BP reading 
will be recorded beat to beat, without any averaging, from the A-line and from the LiveMetric 
device). The mean and experimental standard deviation of the SYS and DIA BP from the record-
ings will be determined.  
Since there is no cuff inflation interruption by the LiveMetric device, the A-line ranges shall be 
determined from the recording for a duration of 30 seconds, while simultaneously recording the 
same period of the data point from the LiveMetric device.  
The reference SYS is defined as the range of a ± 1 experimental standard deviation around the 
mean value of the invasive systolic BP values obtained during the data point range performed by 
the LiveMetric device. The reference DIA BP is defined as the range of ±1 experimental standard 
deviation around the mean value of the invasive diastolic BP values obtained during the same 
period. 
Isolated VPB’s shall be addressed by removing the pressure pulse associated with the VPB and 
the following compensatory beat. 
 

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9.3.2. 
If the value obtained from the LiveMetric determination lies within the range of the reference BP 
as determined in (Error! Reference source not found.), assign an error of 0 mmHg (0 kPa) to 
this determination.  
If the value obtained from the LiveMetric determination lies outside the range of the reference BP 
as determined in (Error! Reference source not found.) subtract the value of the determination 
from the adjacent limit of the range of the variation of BP. That difference represents the error for 
this determination. 
The arithmetic mean of the error is calculated and its experimental standard deviation from the 
errors of each recording for each BP value (SYS & DIA) and determination for each patient.  
 
9.3.3. Data Analysis 
The data set will be collected for clinical investigation purposes andwill be processed and ana-
lyzed according to the formulas provided in the ISO 81060-2: 2013. 
The lateral difference will be calculated initially as the average difference between the readings 
or determination made on each limb according to Formula: 
𝐿𝐷= 1
3  × () 𝑃𝑖
,
-./
−) 𝑃𝑗
,
2./
3; 
i is the index for the determination on the limb used for the sphygmomanometer-under-test de-
termination; 
j is the index for the reading on the limb used for the reference reading. 
Only data within the inclusion criteria as defined in section (Error! Reference source not found.) 
will be processed for the purpose of clinical investigations.  
The mean value of the errors for SYS and DIA BP,  xn of the n individual paired determination of 
the LiveMetric device as determined above for all subjects, will be calculated according to For-
mula: 
𝑋67 = 1
𝑛 × ) 𝑋/
7
2./
 
and Formula: 
𝑆7 = :
1
𝑛−1 × )(𝑋- −𝑋67)
7
2./
 
Where; 
 𝑋/ is the error of the ith individual determination as determined in (Error! Reference source not 
found.);  

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n is the total number of determinations;  
i is the index for the individual determination. 
Mean or standard deviation outside the specified ranges above, mandate further algorithm mod-
ification until subsequent testing with new data sets done in accordance with this protocol meets 
the above criteria. 
 
9.3.4. Analysis of the Primary Efficacy Endpoint 
Primary Endpoint is determined by meeting the success criterion for SYS and DIA BP as defi-
ned by ISO 81060-2: 2013 
9.5. Sample Size 
As determined in ISO 81060-2 / 2013; a reference invasive BP monitoring equipment clinical investigation 
shall consist of a minimum of 15 patients. For each patient shall be a minimum of 150 valid BP measure-
ments in the clinical investigation.  
The goal sample size is 15 patients. It is expected that 25 patients will need to be screened to obtain the 
desired sample size. 
 
 
9.6. Measures to Minimize Bias 
Blinding is not an option in this investigation. All subjects will utilize both the intra-arterial blood pressure 
monitor which is already in place and the wristband that is applied during the study. 
 
10. Source Documents and Access to Source Data/Documents 
 
 
Source data is all information, original records of clinical findings, observations, or other activities in a clin-
ical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in source 
documents.  Examples of these original documents, and data records include: hospital records, clinical 
and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dis-
pensing records, recorded data from automated instruments, copies or transcriptions certified after verifi-
cation as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic me-
dia, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical 
departments involved in the clinical trial. It is acceptable to use CRFs as source documents. If this is the 
case, it should be stated in this section what data will be collected on CRFs and what data will be col-
lected from other sources. 
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data re-
quested on the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is left 
blank because the procedure was not done or the question was not asked, write “N/D”.  If the item is not 
applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any entry 
error has been made, to correct such an error, draw a single straight line through the incorrect entry and 
enter the correct data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the 
item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government regula-
tory bodies, and University compliance and quality assurance groups of all study related documents (e.g. 
source documents, regulatory documents, data collection instruments, study data etc.).  The investigator 
will ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
 

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Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
 
11. Quality Assurance and 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 SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and re-
ports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
 
 
12. Ethics/Protection of Human Subjects 
12.1. Ethical Standard 
 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protec-
tion of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or 
the ICH E6. 
 
12.2. Institutional Review Board 
 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submit-
ted to the IRB for review and approval. Approval of both the protocol and the consent form must be ob-
tained 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. All changes to the consent form will be IRB 
approved; a determination will be made regarding whether previously consented participants need to be 
re-consented. 
 
12.3. Informed Consent Process 
 
12.3.1. Consent/Assent and Other Informational Documents Provided to Participants 
An IRB-approved consent script will be provided to the patient and verbal consent will be obtained from 
the subject or LAR. 
12.3.2. Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Discussion of risks and possible benefits of 
participation will be provided to the participants and their families. Consent forms will be IRB-approved 

Study number: 17-00884 
 
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and the participant or the Legal Authorized Representative will be asked to read and review the docu-
ment. The investigator will explain the research study to the participant and answer any questions that 
may arise. All participants will receive a verbal explanation in terms suited to their comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research participants. Partici-
pants will have the opportunity to carefully review the consent script and ask questions prior to signing. 
The participants should have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. The participant will provide verbal informed consent prior to any proce-
dures being done specifically for the study. The participants may withdraw consent at any time throughout 
the course of the trial. A copy of the consent script will be given to the participants for their records. How-
ever, a signed informed consent will not be requested as this would only create additional PHI documents 
that would need to be protected. The rights and welfare of the participants will be protected by emphasiz-
ing to them that the quality of their medical care will not be adversely affected if they decline to participate 
in this study. 
 
Only verbal consent will be obtained. A signed informed consent document will not be stored in the sub-
ject’s research record. We are requesting a waiver of written documentation of consent and a waiver of 
HIPAA authorization because the only record linking the subject and the research would be the consent 
document, and the principal risk of the research would be potential harm resulting from a breach of confi-
dentiality.   
 
 
12.4. Participant and Data Confidentiality 
No PHI will be collected. All data will be stored anonymously.  
No signed consent documents will exist. Only verbal consent will be obtained. 
Data collection will end at the time the wristband is removed. 
 
13. Data Handling and Record Keeping 
 
13.1 Data Collection and Management Responsibilities 
 
Only anonymous data will be collected. No PHI will be retained. 
Anonymous data will be recorded and saved electronically. 
Intra-arterial blood pressure monitor data will be recorded automatically as per ICU standards. 
Data collection will be the responsibility of the investigators and will be stored on REDCap. 
 
13.1. Study Records Retention 
 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final report-
ing/publication, or 2 years after the last approval of a marketing application is approved for the drug for 
the indication for which it is being investigated or 2 years after the investigation is discontinued and FDA 
is notified if no application is to be filed or if the application has not been approved for such indication. No 
records will be destroyed without the written consent of the sponsor, if applicable. It is the responsibility of 
the sponsor to inform the investigator when these documents no longer need to be retained. 
 
13.2. Protocol Deviations 
Any deviation in protocol will be reviewed by the investigators to determine if data from the involved sub-
jects can be included. If not, additional subjects will be required to obtain the goal sample size. 
 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, or 

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the study site staff. As a result of deviations, corrective actions are to be developed by the site and imple-
mented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is re-
sponsible for knowing and adhering to their IRB requirements. Further details about the handling of proto-
col deviations will be included in the MOP. 
 
13.4. Publication and Data Sharing Policy 
 
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 man-
uscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical 
trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any research 
project that prospectively assigns human subjects to intervention or concurrent comparison or control 
groups to study the cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care 
changes, and the like. Health outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and 
the Section 801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine. Other biomedical journals are considering adopting similar policies. For interventional 
clinical trials performed under NIH IC grants and cooperative agreements, it is the grantee’s responsibility 
to register the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether registration is 
necessary; instead, the committee recommends that researchers who have questions about the need to 
register err on the side of registration or consult the editorial office of the journal in which they wish to 
publish. 
 
FDAAA mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register 
and report results of certain "applicable clinical trials": 
 
• Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations 
of a product subject to FDA regulation; 
• Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation 
(other than small feasibility studies) and pediatric postmarket surveillance studies. 
• NIH grantees must take specific steps to ensure compliance with NIH implementation of FDAAA. 
 
14. Study Finances 
14.1. Funding Source 
LiveMetric will provide the investigational wristband device. No other funding is being received. 
 
14.2. Costs to the Participant 
There is no cost to the subject for participation in this study. 
 

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14.3. Participant Reimbursements or Payments 
No compensation will be provided for participation in this study. 
 
15. Study Administration 
This study includes only the investigators listed in prior sections. 
16. Conflict of Interest Policy 
All investigators will follow the applicable Conflict of Interest policies related to research. See: 
https://nyumc.ellucid.com/documents/view/1119   
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore any actual conflict of interest of persons who have a role in the design, con-
duct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, per-
sons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the trial  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Management Unit (CIMU) with a Committee-sanctioned conflict management 
plan that has been reviewed and approved by the study sponsor prior to participation in this study. All 
NYULMC investigators will follow the applicable conflict of interest policies. 
 
 
 

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17. References 
 
Chung E, Chen G, Alexander B, Cannesson M. Non-invasive continuous blood pressure monitoring: a 
review of current applications. Front Med. 2013;7(1):91-101. 
 
Lehman LW, Saeed M, Talmor D, Mark R, Malhotra A. Methods of blood pressure measurement in the 
ICU. Crit Care Med. 2013;41:34–40. doi: 10.1097/CCM.0b013e318265ea46. 
 
McGhee BH and Bridges EJ. Monitoring arterial blood pressure: What you may not know. Crit Care 
Nurse. 2002;22:60-79. 
 
Henneman E and Henneman P. Intricacies of blood pressure measurement. Heart Lung. 1989;19:263-
273. 
 
 
 
 
 
 
 

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18. Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments. 
 
1. Consent Script 
2. Waiver for written consent