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Clinical trial of pulse oximetry saturation

Clinical trial of pulse oximetry saturation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078777
Enrollment
Unknown
Registered
2023-12-18
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

None listed

Interventions

Gold Standard:CO oximeter method for measuring SaO2
Index test:SpO2 corresponding to the blood oxygen sensor at the time of blood draw

Sponsors

Shenzhen Hospital of Hong Kong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1) The subjects are adult, pediatric, and neonatal patients who need to monitor SpO2 values and blood gas measurements, including both males and females; 2) The skin color of the subjects can be light skin, normal skin, with varying degrees of melanin deposition, or dark skin (the skin color level of the subjects can refer to the commonly used clinical classification scale "Fitzpatrick"); 3) The fingers of adult or pediatric subjects can be monitored for SpO2, while the limbs of newborn subjects can be monitored for SpO2 (meeting blood oxygen monitoring conditions); 4) The subject or their guardian must understand the clinical trial, agree to participate in the clinical trial, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) The subject or their guardian does not understand the clinical trial and its risks; 2) Before collecting blood gas from newborn patients, the SpO2 of the right hand and any lower limb of the newborn should be tested using a commercially available VS 9 vital sign monitor and a commercially available newborn blood oxygen sensor. If the difference between the two is greater than 3%, newborns whose subsequent blood collection site is the right radial artery will not participate in the experiment; 3) Patients deemed unsuitable by the researchers after evaluation to participate in this clinical trial (including patients with factors affecting blood oxygen measurement); 4) Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Mean Bias;Precision;Accuracy;

Countries

China

Contacts

Public ContactShi Xiaoyong

Shenzhen Hospital of Hong Kong University

shixy@hku-szh.org+86 139 2529 2540

Outcome results

None listed

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