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Clinical trial on safety and effectiveness of pulse oximetry function (SpO2&Pulse rate) of Justec's Patient monitor, wrist pulse oximeter and probes

Clinical trial on safety and effectiveness of pulse oximetry function (SpO2&Pulse rate) of Justec's Patient monitor, wrist pulse oximeter and probes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108344
Enrollment
Unknown
Registered
2025-08-28
Start date
2024-02-20
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

None listed

Interventions

The test medical device group and the control medical device group:None

Sponsors

Sir Run Shaw Hospital, Zhejiang University School of Medicine
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 study steps; 3.Healthy adult subjects aged 18 to 45; 4.COHbl0g/dL; 5.Allen test is passed; 6.Within one month before the experiment, blood routine, urine routine, liver function, kidney function, electrocardiogram, chest X-ray examination was normal, or slightly abnormal but there was no clinical significance. Pregnancy was excluded by HCG test in women.

Exclusion criteria

Exclusion criteria: 1.Smoker and subjects exposed to carbon monoxide; 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.Physical deformity can not normally wear the pulse oximeter probe; 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
The accuracy of SpO2 measurement;

Secondary

MeasureTime frame
Pulse rate accuracy;

Countries

China

Contacts

Public ContactZhou Dachun

Sir 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