Testing of the BOLT device to evaluate its performance which measures Blood Pressure,Body temperature, Oxygen Saturation and Pulse.
Not Applicable
Completed
- Conditions
- Health Condition 1: R030- Elevated blood-pressure reading, without diagnosis of hypertensionHealth Condition 2: R509- Fever, unspecifiedHealth Condition 3: R031- Nonspecific low blood-pressure readingHealth Condition 4: R068- Other abnormalities of breathingHealth Condition 5: R009- Unspecified abnormalities of heartbeat
- Registration Number
- CTRI/2018/12/016558
- Lead Sponsor
- American Megatrends India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 193
Inclusion Criteria
1. Subject is willing to give written informed consent for participation in the study.
2. Male or Female, aged 18 years or above.
3. Subjects having one or more following medical history.
a) Blood Pressure
b) Fever
c) Low oxygen saturation level.
Exclusion Criteria
1. Geriatric subjects above 75 years of age.
2. Mentally challenged subjects.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For all the below parameters the measurement by test and reference <br/ ><br>values will be compared <br/ ><br>1. Blood Pressure (BP) <br/ ><br>2. Body Temperature <br/ ><br>3. Blood Oxygen saturation (SpO2) <br/ ><br>4. PulseTimepoint: Same Day
- Secondary Outcome Measures
Name Time Method Ease of use of test device will be determined as per the list of <br/ ><br>questionnaires.Timepoint: Same Day;Ease of use of test device will be determined as per the list of <br/ ><br>questionnaires.Timepoint: Same Day