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

Not Applicable

Suspended

• Registration Number: CTRI/2020/12/029512
• Lead Sponsor: Conzumex Industries Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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 �2.0% FCOHb

5.Hemoglobin value is greater than or equal to 11g/dL

6.Baseline heart rate �45bpm and �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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>I.Goldââ?¬?standardââ?¬? measurements of blood SaO2 by a CO ââ?¬? OXIMETER <br/ ><br>II.In comparison to hospital grade pulse oximeter <br/ ><br>III.In comparison to Over the counter pulse oximeter <br/ ><br>Timepoint: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use

Secondary Outcome Measures

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