Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Laval University
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: During procedure (arterial blood gas sample collection)
Difference between Nonin oximeter SpO2 and the SaO2 value
Secondary Outcomes
- Hypoxemia detection(During procedure (arterial blood gas sample collection))
- Overestimation and underestimation of SaO2(During procedure (arterial blood gas sample collection))
Investigators
François Lellouche
Principal Investigator
Laval University