Recruiting

Oxygenation Targets

Sponsor:

Laval University

Code:

NCT05590130

Conditions

Oxygen Toxicity

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

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

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

Study Details

Brief summary:

The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.

The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.

NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).

Conditions

Oxygen Toxicity

Respiratory Failure

Study ID

NCT05590130

Start date

Nov 16, 2022

Status verified date

Aug, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 18 years of age
  • Patients admitted to postoperative cardiac surgery intensive care unit
  • Presence of an arterial catheter Specific for the extubate patient
  • Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
  • SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21

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 ...) Specific for the extubate patient
  • Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nonin oximeter with a 90% SpO2 target

During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.

experimental: Philips oximeter with a 90% SpO2 target

During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.

experimental: Nonin oximeter with a 94% SpO2 target

During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.

experimental: Philips oximeter with a 94% SpO2 target

During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.

Interventions

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

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter

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

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter

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

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

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

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

Primary outcome measure

  • Oxygen flow (or FiO2) [ Time Frame: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10) ]

Central Contacts and Locations

Central contacts

Francois Lellouche

418656-8711francois.lellouche@criucpq.ulaval.ca

Pierre Alexandre Bouchard

418656-8711pierre-alexandre.bouchard@criucpq.ulaval.ca

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

Francois Lellouche

francois.lellouche@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-09-04.