Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy

Not Applicable

Not yet recruiting

• Conditions: Oxygen Delivery; Hypoxemic Acute Respiratory Failure; Acute Respiratory Failure; High Flow Oxygen Therapy

• Registration Number: NCT07168213
• Lead Sponsor: Laval University

Brief Summary

Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.

Detailed Description

The oximeters evaluated will be the Nonin (Plymouth, MN) and the Philips (Eindhoven, Netherlands). Two SpO2 targets will be evaluated: 90% and 94%.

A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.

At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.

Study Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-10-01
• Primary Completion: 2027-06
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ≥ 18 years of age
• Admiitted in intensive care unit
• Presence of an arterial catheter
• Ongoing on high flow nasal oxygen therapy with SpO2 between 88 and 100% with a FiO2 between 40 and 80% with the usual oximeter .

Exclusion Criteria

• No SpO2 signal with oximeter in use
• False nails or nail polish
• Methemoglobinemia >0.015 on last available arterial gas
• Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...)
• Expected to use another respiratory support within two hour of inclusion (NIV or mechanical ventilation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
FiO2	Mean FiO2 in the two last minute of each study period between minute 8 and 10	FiO2 at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter

Secondary Outcome Measures

Name	Time	Method
Difference between SpO2 and SaO2	assessed up to 10 minutes - at the same of the arterial blood gases punction	Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)
High flow weaning criteria	Mean FiO2in the two last minute of each study period (between minute 8 and 10)	Percentage of patient whose average FiO2 level below 40%
Intensive care unit transfert criteria	Mean FiO2in the two last minute of each study period (between minute 8 and 10)	Percentage of patients whose average FiO2 level over 60%
Intubation criteria	Mean FiO2in the two last minute of each study period (between minute 8 and 10)	Percentage of patients whose average FiO2 level over 80%
Mean difference on oxymeter	assessed up to 10 minutes - at the same of the arterial blood gases punction	Mean (±SD) of the gaps between the different oximeters tested

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Québec, Quebec, Canada