Respiratory Rate Validation Study - ChroniSense Polso

NCT05246358 | Completed FDA Device

• 1 other identifier: PR 2020-414
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• Arms accuracy (breaths per minute) of Polso Monitoring System relative to End Tidal Carbon Dioxide monitor-derived respiration rate

  Accuracy of Polso Monitoring System (DUT) relative to a reference End Tidal Carbon Dioxide monitor-derived respiration rate (REF). Polso reports respiration rate (breaths per minute) directly, at 60 second intervals. End Tidal Carbon Dioxide monitor waveforms will be hand-scored, based on respiration waveform peaks, to derive respiration rate (breaths per minute). The readings from each device will be synchronized to achieve paired simultaneous respiration rates, and aggregated into calculation of a comparative accuracy measure, namely Accuracy root-mean-square (Arms) difference, in breaths per minute, between the Polso (DUT) and the reference (REF) respiratory rate system, for all stable respiratory periods. Acceptance criteria Arms \<3.

  Through study completion, 1 month average

Study Arms (1)

ChroniSense Polso Respiratory Rate

EXPERIMENTAL

Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed

Device: ChoniSense Polso

Interventions

ChoniSense Polso DEVICE

A range of stable respiratory rates was elicited from each volunteer test subject. The rates were 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers. Each subject was 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 was used as the Accuracy Reference Device (Reference) in this study.

ChroniSense Polso Respiratory Rate

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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, or a smoker who has refrained from smoking for 1 day.
• Male or female of any race

You may not qualify if:

• 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. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
• 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:
• high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg
• 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 Desaturation Laboratory, Site ID# 001

Louisville, Colorado, 80027, United States

Location

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: January 23, 2022
• First Posted: February 18, 2022
• Study Start: May 10, 2021
• Primary Completion: May 14, 2021
• Study Completion: June 11, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)