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Neonatal Oximeter Bias Study

NCT06817850 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Neonatal Respiratory Distress
  • Oxygenation

Sponsors & Collaborators

  • University Hospital, Motol

    collaborator OTHER

  • Czech Technical University in Prague

    lead OTHER

Principal Investigators

  • Thomas E Bachman, MSc · Czech Technical University in Prague

  • Jan Janota, MD, PhD · Motol University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817850 on ClinicalTrials.gov