Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
- Conditions
- Respiratory FailureHyperoxemiaHypoxemia
- Interventions
- Device: SpO2 and SaO2 comparison
- Registration Number
- NCT06102499
- Lead Sponsor
- Laval University
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- ≥ 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult population SpO2 and SaO2 comparison Adult population \>or= 18 years old (estimated 100 patients) Pediatric population SpO2 and SaO2 comparison Pediatric population \< 18 years old (estimated 100 patients)
- Primary Outcome Measures
Name Time Method Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases During procedure (arterial blood gassample collection) Difference between Nellcor oximeter SpO2 and the SaO2 value
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases During procedure (arterial blood gas sample collection) Difference between GE oximeter SpO2 and the SaO2 value
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases During procedure (arterial blood gas sample collection) Difference between Masimo oximeter SpO2 and the SaO2 value
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases During procedure (arterial blood gas sample collection) Difference between Nonin oximeter SpO2 and the SaO2 value
- Secondary Outcome Measures
Name Time Method Hypoxemia detection During procedure (arterial blood gas sample collection) Ability to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)
Overestimation and underestimation of SaO2 During procedure (arterial blood gas sample collection) Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.
Trial Locations
- Locations (3)
CHUM
🇨🇦Montréal, Quebec, Canada
CHU Ste-Justine
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Quebec, Canada