RecruitingNot Applicable

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

Canada200 participantsStarted 2024-06-20

Plain-language 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

Who can participate

Age range

0 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: During procedure (arterial blood gas sample collection)

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

Timeframe: During procedure (arterial blood gassample collection)

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

Timeframe: During procedure (arterial blood gas sample collection)

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

Timeframe: During procedure (arterial blood gas sample collection)

Trial details

NCT IDNCT06102499

SponsorLaval University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

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