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Clinical trial study on the safety and effectiveness of the pulse oximetry function of Redy-Med SpO2 Sensor

Clinical trial study on the safety and effectiveness of the pulse oximetry function of Redy-Med SpO2 Sensor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122415
Enrollment
Unknown
Registered
2026-04-13
Start date
2021-05-22
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Blood oxygen function

Interventions

Trial group:Repetitive blood oxygen probes and disposable blood oxygen probes

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form by the subject or by a legally authorized representative 2. Subjects should be able to follow research steps 3. Healthy adult volunteers, aged 18 to 45 4. COHb = 10 g/dL 5. Allen test passed 6. The result of medical examination should be normal, or abnormal but no clinical significance. Medical examinations include blood routine, urine routine, liver function, renal function, electrocardiogram and chest X-ray. Female subjects will be examined HCG to exclude pregnancy

Exclusion criteria

Exclusion criteria: 1. Smoker and subjects exposed to high carbon monoxide gas for a long time; 2. Skin infection at arterial puncture site; 3. Subject with respiratory infections recently; 4. Subject with chronic heart and lung disease; 5. Subject in pregnancy or lactating; 6. Blood donor within three months; 7. Subject who has participated in other clinical trials within three months; 8. PI believes that the person is not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
SpO2 accuracy;

Countries

China

Contacts

Public ContactZhou Dachun

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

zhoudc86@163.com+86 135 8870 8510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026