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NCT Number: NCT07168213

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

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.

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Key information

Conditions

Oxygen Delivery Acute Respiratory Failure High Flow Oxygen Therapy Hypoxemic Acute Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V4G5, Canada

Location status: Recruiting

Location contact

Francois Lellouche

CONTACT

[email protected]

418-656-8711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Manual FiO2 titration with Philips oximeter (SpO2 target 90%)

Device

FiO2 titration to reach the SpO2 target (set at 90%) with Philips oximeter

Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)

Device

FiO2 titration to reach the SpO2 target (set at 90%) with Nonin oximeter

Manual FiO2 titration with Philips oximeter (SpO2 target 94%)

Device

FiO2 titration to reach the SpO2 target (set at 94%) with Philips oximeter

Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)

Device

FiO2 titration to reach the SpO2 target (set at 94%) with Nonin oximeter

Primary outcomes

  1. FiO2

    Time frame: 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 outcomes

  1. Difference between SpO2 and SaO2

    Time frame: 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)

  2. High flow weaning criteria

    Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)

    Percentage of patient whose average FiO2 level below 40%

  3. Intensive care unit transfert criteria

    Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)

    Percentage of patients whose average FiO2 level over 60%

  4. Intubation criteria

    Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)

    Percentage of patients whose average FiO2 level over 80%

  5. Mean difference on oxymeter

    Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction

    Mean (±SD) of the gaps between the different oximeters tested

Study contacts

Contact information is provided by the study sponsor or research team.

Francois Lellouche Principal Investigator

CONTACT

[email protected]

418-656-8711 ext. 3572

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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