Clinical Investigation of New Pulseoxymetry Device
Phase 4
Completed
- Registration Number
- CTRI/2021/10/037193
- Lead Sponsor
- Skanray India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
1)Non-smokers
2)Healthy; no known blood disorders
3)Finger sizes within the sensor specifications
4)Minimum 18 years of age
5)Hb > 10 g/dl
Exclusion Criteria
1)Artificial nails or fingernail polish
2)Subjects who would be placed at undue medical RISK associated with any PROCEDURES called for in the protocol; a previous or current diagnosis of anemia, asthma, heart/circulatory disease, high blood pressure, emphysema, or an epilepsy or seizure disorder
3)Being diagnosed with pneumonia during the previous year
4)Being a habitual tobacco smoker
5)Having lived at altitudes above 5,000 ft three months prior to being enrolled
6)History of having Claustrophobia
7)Pregnant Female
8)History of alcohol intake in last 48 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures: <br/ ><br>1. To Pulseoximetry values as measured using OXYSKAN device before, during and after the controlled desaturation.Timepoint: 1. Pulse oximetry values using OXYSKAN before, during and after controlled desaturation.
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures: <br/ ><br>1. To record comparative accuracy data pulseoximetre OXYSKAN with given standard deviceTimepoint: 1. Pulseoximetry values as measured simultaneously using OXYSKAN and given standard device before, during and after the controlled desaturation.