Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

Last updated: August 27, 2025
Sponsor: Laval University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

SpO2 and SaO2 comparison

Clinical Study ID

NCT06102499
22373
  • Ages < 100
  • All Genders

Study Summary

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (General Electric-GE, Medtronic, Masimo and Nonin) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation

Eligibility Criteria

Inclusion

Adult population

Inclusion Criteria:

  • ≥ 18 years old (adult population) -

  • Patients admitted to the Intensive Care Unit

  • Artery catheter already installed

Pediatric population

  • Below 18 years old

  • Patients admitted to the Intensive Care Unit

  • Artery catheter already installed

Exclusion

Exclusion Criteria:

  • No or poor signal with the usual pulse oximeter/based on clinician judgment

  • High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)

  • Pigmented nails or nail polish

  • Methemoglobinemia history

  • Hemoglobin below 80 g/L

  • Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…)

  • Prone position, Extra Corporel Membrane Oxygenator

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: SpO2 and SaO2 comparison
Phase:
Study Start date:
June 20, 2024
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • CHU Ste-Justine

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • CHUM

    Montréal, Quebec H2X0A9
    Canada

    Site Not Available

  • CHU Ste-Justine

    Montreal 6077243, Quebec 6115047 H3T 1C5
    Canada

    Site Not Available

  • CHUM

    Montreal 6077243, Quebec 6115047 H2X0A9
    Canada

    Active - Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec 6325494, Quebec 6115047 G1V 4G5
    Canada

    Site Not Available

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Quebec, G1V 4G5
    Canada

    Site Not Available

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