Clinical trial NCT06102499: Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Official title: Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Failure
Hypoxemia
Hyperoxemia
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient in ICU with arterial catheter already installed will be consider

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


Eligibility criteria: 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

Primary outcomes:
measure: Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
timeFrame: During procedure (arterial blood gas sample collection)
measure: Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
timeFrame: During procedure (arterial blood gassample collection)
measure: Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
timeFrame: During procedure (arterial blood gas sample collection)
measure: Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
timeFrame: During procedure (arterial blood gas sample collection)
Secondary outcomes:
measure: Overestimation and underestimation of SaO2
timeFrame: During procedure (arterial blood gas sample collection)
measure: Hypoxemia detection
timeFrame: During procedure (arterial blood gas sample collection)
Other outcomes:
measure: Hyperoxemia detection
timeFrame: During procedure (arterial blood gas sample collection)
measure: Gaps between the different oximeters
timeFrame: During procedure (arterial blood gas sample collection)
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Montréal
country: Canada
facility: CHU Ste-Justine
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
References: