Status:
COMPLETED
Respiratory Rate Validation Study - ChroniSense Polso
Lead Sponsor:
ChroniSense Medical Ltd.
Conditions:
Respiratory Rate
Eligibility:
All Genders
18-52 years
Phase:
NA
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
Detailed Description
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso. A range of stable respiratory rates were elicited fro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
- diabetes,
- 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
- Other known health condition, should be considered upon disclosure in health assessment form
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05246358
Start Date
May 10 2021
End Date
June 11 2021
Last Update
February 18 2022
Active Locations (1)
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1
Clinimark Desaturation Laboratory, Site ID# 001
Louisville, Colorado, United States, 80027