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

Recruitingn/aAges 0 Years - 100 YearsAllLaval University
NCT06102499 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • SpO2 and SaO2 comparison
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Where

3 sites
CHUM
Montreal, Canada
CHU Ste-Justine
Montreal, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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