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Clinical Accuracy Validation of Oximeter in Human Subjects Clinical Trial

Clinical Accuracy Validation of Oximeter in Human Subjects Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080646
Enrollment
Unknown
Registered
2024-02-04
Start date
2021-09-10
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

None listed

Interventions

NA:Oxygen reduction

Sponsors

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1)People who are participating in the clinical trial voluntary and singed Informed Consent. 2)People between 18 and 50 years old. No gender limit. 3)COHbl0g/dL. 4)People with normal Allen test results. 5)The classification of ASA is level 1. 6)The people with the normal results or abnormal results with no clinical significance of the blood routine examination, urine routine examination, liver function test, electrocardiographic examination, and Chest X-ray examination.

Exclusion criteria

Exclusion criteria: 1)Smokers, or people exposed to environments with higher carbon monoxide content. 2)Subjects who may be harmed by clinical trials. 3)People who cannot obtain full informed consent due to mental disorders. 4)People with platelet count less than 60×109/L or those with coagulopathy; 5)People suffering from respiratory diseases. 6)People suffering from heart disease or cardiovascular disease. 7)Women who are pregnant or breastfeeding. 8)People who are suspected or diagnosed with a history of alcohol or drug abuse. 9)Injured, disabled, and physically deformed. 10)Those whom the investigators think are not suitable to participate in this clinical trial due to other reasons. 11)Those who have participated in other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
The accuracy of SpO2 measurement;

Secondary

MeasureTime frame
The equivalence of pulse rate;

Countries

China

Contacts

Public ContactZhou Dachun

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

zhoudc86@163.com+86 571 8609 0073

Outcome results

None listed

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