Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor

NCT05210712 | Completed DMC FDA Device

• 1 other identifier: 2021-462
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).

Conditions

A Minimum of 30 Adults, Ages 18 Years and Older

Outcome Measures

Primary Outcomes (1)

• Accuracy of the device to Reference

  The primary objective of this study is to compare the accuracy of the device under test for the measurement of respiratory rate to the Reference, which is an End Tidal Carbon Dioxide Monitor (EtCO2). For final validation, the EtCO2 waveform will be scored by counting the respiratory peaks per minute.

  1 to 3 minutes at a given level

Interventions

RS001.2 Respiree Cardio-Respiratory Monitor DEVICE

The RS001.2 Respiree Cardio-Respiratory Monitor is intended as a noninvasive multiparameter monitor on the adult population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include a minimum of 30 healthy competent adults, ages 18 years and older. A maximum of 60 subjects will be enrolled. The subject selection will be a mix of males and females with small to large physiques. An attempt will be made to enroll a variety of skin tones. The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger. The subjects must understand the study and consent to participate by signing the Informed Consent Form. Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.

You may qualify if:

• Subject must have the ability to understand and provide written informed consent
• Subject must be ≥18 years of age
• Subject must be willing and able to comply with study procedures and duration
• Male or female of any race
• Baseline SpO2 ≥85%
• At least 3 subjects (10% of a total 30 subjects) will have a history of smoking

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Subjects who refuse or are unable to provide to sign an informed written consent for study
• Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study
• 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,
• Severe COPD
• Subjects with self-reported heart or cardiovascular conditions such as:
• high blood pressure: systolic \>160 mmHg or diastolic \>100 mmHg on 3 consecutive readings (reviewed during health screen)
• have had cardiovascular surgery
• chest pain (angina)

Sponsors & Collaborators

• Respiree Pte Ltd: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 27, 2022
• Study Start: January 24, 2022
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)