Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation (Oxygap pong)

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).

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Oxygen Toxicity
• Intervention / Treatment: Device: Manual oxygen titration with Nonin oximeter (SpO2 target 90%); Device: Manual Oxygen titration with Philips oximeter (SpO2 target 90%); Device: Manual oxygen titration with Nonin oximeter (SpO2 target 94%); Device: Manual Oxygen titration with Philips oximeter (SpO2 target 94%)

Detailed Description

The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).

Two SpO2 targets will be assessed: 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.

The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francois Lellouche; Phone Number: 3572 418656-8711; Email: francois.lellouche@criucpq.ulaval.ca
• Study Contact Backup: Name: Pierre Alexandre Bouchard; Phone Number: 2712 418656-8711; Email: pierre-alexandre.bouchard@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Contact: Francois Lellouche; Email: francois.lellouche@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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
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.	Device: 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
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.	Device: 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
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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen flow (or FiO2)	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	Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between SpO2 and SaO2	Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)	assessed up to 10 minutes - at the same of the arterial blood gases punction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference on oxymeter	Mean (±SD) of the gaps between the different oximeters tested	assessed up to 10 minutes - at the same of the arterial blood gases punction
Partial oxygen weaning	Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Complete oxygen weaning	Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Respiratory support escalation	Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Occult hypoxemia	Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%)	assessed up to 10 minutes - at the same of the arterial blood gases punction
Occult hyperoxemia	Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%)	assessed up to 10 minutes - at the same of the arterial blood gases punction

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 22266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No