ChroniSense Polso Wrist Worn Respiration Rate Validation Study

NCT03750344 | Completed FDA Device

• 1 other identifier: PR 2018-305
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Rate

Keywords

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ChroniSense Polso Respiratory Rate

EXPERIMENTAL

Device: Diagnostic test

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ChroniSense Medical Ltd.: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Arthur D Cabrera, MD

  Avista Adventist Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 23, 2018
• Study Start: November 6, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 30, 2018
• Last Updated: February 5, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)