Oxygap 2: Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pediatric population Pediatric population < 18 years old (estimated 100 patients) |
Device: SpO2 and SaO2 comparison
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
|
| Adult population Adult population >or= 18 years old (estimated 100 patients) |
Device: SpO2 and SaO2 comparison
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
|
Outcome Measures
Primary Outcome Measures
- 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 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 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
- Overestimation and underestimation of SaO2 [During procedure (arterial blood gas sample collection)]
Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.
- Hypoxemia detection [During procedure (arterial blood gas sample collection)]
Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)
Other Outcome Measures
- Hyperoxemia detection [During procedure (arterial blood gas sample collection)]
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)
- Gaps between the different oximeters [During procedure (arterial blood gas sample collection)]
Average of the SpO2 value gaps between the different oximeters tested
Eligibility Criteria
Criteria
Adult population
Inclusion Criteria:
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≥ 18 years old (adult population) -
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Patients admitted to the Intensive Care Unit
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Artery catheter already installed
Pediatric population
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Below 18 years old
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Patients admitted to the Intensive Care Unit
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Artery catheter already installed
Exclusion Criteria:
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No or poor signal with the usual pulse oximeter/based on clinician judgment
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High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
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Pigmented nails or nail polish
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Methemoglobinemia history
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Hemoglobin below 80 g/L
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Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…)
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Prone position, Extra Corporel Membrane Oxygenator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHUM | Montréal | Quebec | Canada | H2X0A9 |
| 2 | CHU Ste-Justine | Montréal | Quebec | Canada | H3T 1C5 |
| 3 | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Laval University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22373