CTRI/2020/12/029512
Suspended
未知
Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 during hand motion and hand at rest in comparison to ââ?¬Å?goldââ?¬?standardââ?¬? measurements of blood SaO2 by a CO ââ?¬? OXIMETER, hospital grade pulse oximeter and Over the counter pulse oximeter on healthy subjects
Conzumex Industries Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Conzumex Industries Pvt Ltd
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female subjects having Age more than 18 \-50 years with at least 1/3 darkly pigmentation
- •2\.Subjects with BMI 18\.5\-30
- •3\.Subjects wrist size for Female :5\.5ââ?¬•to 6\.5ââ?¬• and Male :6\.5\-7\.5ââ?¬•
- •4\.(Carboxyhemoglobin) Co value ââ?°Â¤2\.0% FCOHb
- •5\.Hemoglobin value is greater than or equal to 11g/dL
- •6\.Baseline heart rate ââ?°Â¥45bpm and ââ?°Â¤85bpm.
- •7\.Subject is willing to give written informed consent
- •8\.Subject is willing and able to comply with all trial requirements
- •9\.A negative pregnancy test result in women of childbearing potential.
Exclusion Criteria
- •1\.The subject is obese (BMI is greater than 30\).
- •2\.The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •3\.Diagnosis of asthma, sleep apnea, or use of CPAP.
- •4\.Subject has diabetes.
- •5\.Subject has a clotting disorder.
- •6\.The subject a hemoglobinopathy or history of anemia
Outcomes
Primary Outcomes
Not specified
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