Neonatal Oximeter Bias Study

NCT06817850 | Not Yet Recruiting

• 1 other identifier: NOB (PRICOIII)
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pulse oximetry; automated FiO2 control; SpO2

Outcome Measures

Primary Outcomes (1)

• Bias between paired SpO2 measurements

  Bias between paired SpO2 in three ranges: 1. Hypoxemia (SpO2: 70 - \<89.5%), 2. Normoxemia (SpO2: 89.5-95.5%) 3. Hyperoxemia (SpO2: \>95.5-100%) The ranges are determined as the mean of the two oximeters.

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

Secondary Outcomes (6)

• Bias between paired SpO2 related to site

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

• Bias between paired SpO2 related to sensor location

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

• Bias between paired SpO2 related to oximeter brand pairs

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

• Bias between paired SpO2 related to sensor pairs

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

• Bias between paired SpO2 related to oximeter averaging setting

  1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)

Study Arms (1)

Infants in the NICU with two oximeters

Infants in the NICU monitored with two oximeters with probes in preductal locations. The use of A-FiO2 is expected.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All infants in the NICU monitored with two simultaneous oximeters with probes in preductal locations. The use of A-FiO2 is expected.

You may qualify if:

• Observations of any infant in the neonatal ICU with two simultaneous oximeter monitors may be included. The sites' Ethics Committee must review the protocol, approve participation and determine if Informed Consent is required. If required, it might be prospective, that is prior to collecting any data, or retrospective.

You may not qualify if:

• One oximeter monitoring post ductal SpO2 in infant with clinically relevant shunt.
• Monitor and A-FiO2 Oximeter not reading between 70-100%
• Less than 5 minutes between repeat Observations
• No more than 5 measurements per day per subject with sensors in same position and same oximeters (i.e., every time either sensor is moved, 5 new Observations can be made that day).
• Presence of motion artifact
• Presence of sensor integrity alarms/alerts

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• University Hospital, Motol: collaborator

Study Sites (1)

Motol University Hospital, Neonatal Unit

Prague, 15500, Czechia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas E Bachman, MSc

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

• Jan Janota, MD, PhD

  Motol University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Rafl, PhD

CONTACT

+420728229991; rafl@fbmi.cvut.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 10, 2025
• Study Start: March 15, 2025
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CZ (1)