Neonatal Oximeter Bias Study

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.

NCT Number	NCT06817850
Lead Sponsor	Czech Technical University in Prague Collaborators: University Hospital, Motol
Conditions	Neonatal Respiratory Distress, Oxygenation
Enrollment	40 participants
Start Date	2025-03-15
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-25