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

Completed

Conditions studied: A Minimum of 30 Adults, Ages 18 Years and Older

In brief

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).

Key facts

Study ID

NCT05210712

Run by

Respiree Pte Ltd

People needed

30

Starts

2022-01-24

Expected to finish

2022-02-10

Last updated by the study team

2022-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (occasional PVCs is acceptable, less than two a minute)
• 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

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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