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NOT YET RECRUITING
NCT06817850

Neonatal Oximeter Bias Study

Sponsor: Czech Technical University in Prague

View on ClinicalTrials.gov

Summary

The study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems. When using A-FiO2 systems there are commonly two oximeter probes on the infant with two difference readouts. Nurses report frustration that the two readings are often markedly different. It is understandable that physiological differences between sensor sites might reflect different regional oxygen saturation levels. It is also possible that there is a relevant systematic bias between difference monitors and sensors. Therefore, a large systematic multicenter study is needed to determine whether these frequent differences should be ignored as physiological noise or considered clinically relevant.

Official title: Evaluation of the Differences Between Simultaneous SpO2s Readings in the NICU: a Multicenter Observational Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-03-15

Completion Date

2025-10-31

Last Updated

2025-03-25

Healthy Volunteers

No

Locations (1)

Motol University Hospital, Neonatal Unit

Prague, Czechia