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NCT Number: NCT06102499

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

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

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Key information

Conditions

Respiratory Failure Hyperoxemia Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Ste-Justine, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

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

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 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

Treatment and study plan

SpO2 and SaO2 comparison

Device

Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

Primary outcomes

  1. Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases

    Time frame: During procedure (arterial blood gas sample collection)

    Difference between GE oximeter SpO2 and the SaO2 value

  2. Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases

    Time frame: During procedure (arterial blood gassample collection)

    Difference between Nellcor oximeter SpO2 and the SaO2 value

  3. Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases

    Time frame: During procedure (arterial blood gas sample collection)

    Difference between Masimo oximeter SpO2 and the SaO2 value

  4. Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases

    Time frame: During procedure (arterial blood gas sample collection)

    Difference between Nonin oximeter SpO2 and the SaO2 value

Secondary outcomes

  1. Overestimation and underestimation of SaO2

    Time frame: During procedure (arterial blood gas sample collection)

    Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.

  2. Hypoxemia detection

    Time frame: During procedure (arterial blood gas sample collection)

    Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)

Other outcomes

  1. Hyperoxemia detection

    Time frame: During procedure (arterial blood gas sample collection)

    Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)

  2. Gaps between the different oximeters

    Time frame: During procedure (arterial blood gas sample collection)

    Average of the SpO2 value gaps between the different oximeters tested

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: Oxygap 2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Aug 28, 2025

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

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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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