ChroniSense Polso Wrist Worn Respiration Rate Validation... | NCT03750344

Studies
ChroniSense Polso Wrist Worn Respiration Rate Validation Study

NCT03750344

Sponsor

ChroniSense Medical Ltd.

Status

Completed

Last Update Posted

Feb 5, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Respiratory Rate

Interventions

Diagnostic test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2018Actual

Primary Completion Date

Nov 9, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Nov 18, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2019

Last Update Posted Date

Feb 5, 2019Actual

Description Module

Brief Summary

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system

Detailed Description

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.

Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study.

Label	Type	Description	Intervention Names
ChroniSense Polso Respiratory Rate	Experimental		Device: Diagnostic test

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic test	Device	Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed	ChroniSense Polso Respiratory Rate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Rate Accuracy of Polso Monitoring System	Respiratory Rate of test subject as compared to CO2 of End Tidal Carbon. Twenty second periods will be averaged to provide one respiratory rate value. Each stable respiratory rate plateau will result in four of these respiratory rate values which will be included in the ARMS calculation. The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the device under test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods. Acceptance criteria ARMS <3	Through study completion, 1 month average

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must have the ability to understand and provide written informed consent
Subject is adult over 18 years of age
Subject must be willing and able to comply with study procedures and duration
Subject is a non-smoker
Male or female of any race
Wrist circumference with the range of 5.5-8 inches (13 to 21cm)

Exclusion Criteria:

Subject is considered as being morbidly obese (defined as BMI >39.5)
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study.
Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, COPD, lung disease
Subjects with self-reported heart or cardiovascular conditions such as:
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury within the last 2 months,
Cancer / chemotherapy
Other known health condition should be considered upon disclosure in health assessment form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis