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

Study Overview
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Brief Summary
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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

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

Conditions
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Respiratory Failure, Hypoxemia, Hyperoxemia

Intervention / Treatment
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* Device: SpO2 and SaO2 comparison


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric population<br>Pediatric population < 18 years old (estimated 100 patients) | Device: SpO2 and SaO2 comparison<br>* 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<br>|
| Adult population<br>Adult population >or= 18 years old (estimated 100 patients) | Device: SpO2 and SaO2 comparison<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between GE oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | 
| Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Nellcor oximeter SpO2 and the SaO2 value | During procedure (arterial blood gassample collection) | 
| Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Masimo oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | 
| Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Nonin oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overestimation and underestimation of SaO2 | Percent of pairs with overestimation and underestimation of SaO2 for each oximeter. | During procedure (arterial blood gas sample collection) | 
| Hypoxemia detection | Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg) | During procedure (arterial blood gas sample collection) |