Status:
COMPLETED
Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor
Lead Sponsor:
Respiree Pte Ltd
Conditions:
A Minimum of 30 Adults, Ages 18 Years and Older
Eligibility:
All Genders
18+ years
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 monit...
Detailed Description
After IRB approval, a minimum of 30 volunteer test subjects will be enrolled for the final validation study population. A maximum of 60 subjects will be enrolled. All subjects will be 18 or older and ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- cardiomyopathy
- Self-reported health conditions as identified in the Health Assessment Form
- 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
- Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
- Other known health condition, should be considered upon disclosure in health assessment form
Key Trial Info
Start Date :
January 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05210712
Start Date
January 24 2022
End Date
February 10 2022
Last Update
May 2 2022
Active Locations (1)
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1
Clinimark
Louisville, Colorado, United States, 80027