Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation

NCT05590130 · tracked via the Priya Life Science Canada tracker

Sponsor

Laval University

Phase

Not applicable

Started

2022-11-16

Last updated

2025-09-04

Condition(s) studied

Oxygen ToxicityRespiratory Failure

Investigational drug(s) / intervention(s)

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%)

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Oxygen flow (or FiO2) — Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter

Trial sites (1)

Facility	City	Region	Status
Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05590130 on ClinicalTrials.gov ↗ ← All trials in Canada