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Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker on healthy subjects.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029512
Enrollment
40
Registered
2020-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Wrist based health tracker device: Calibration on 20 subjects Each day 4 subjects so one week max Control Intervention1: goldââ?¬?standardââ?¬? measurements of blood SaO2 by a CO ââ?

Sponsors

Conzumex Industries Pvt Ltd
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
ââ???Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 ranges (100-97, 97-92, 92-85, 84-78) during hand motion in in comparison to I.Goldââ?¬?standardââ?¬? measurements of blood SaO2 by a CO ââ?¬? OXIMETER II.In comparison to hospital grade pulse oximeter III. In comparison to Over the counter pulse oximeter Timepoint: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use—

Secondary

MeasureTime frame
1. Means for delivering medical-grade oxyg/en-nitrogen mixtures of varying fractional inspired oxygen (FiO2) levels. 2. To evaluate safety and performance of device Timepoint: SpO2 ranges (100-97, 97-92, 92-85, 84-78) one time use—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026