Clinical trial NCT04772183: OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase
Official title: OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Failure
Hypoxemia
Hyperoxemia
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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 (Nonin, Masimo, Philips, Nellcor) 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: Inclusion Criteria:

* ≥ 18 years old
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Exclusion Criteria:

* No signal with the oximeter
* Pigmented nails or nail polish
* Methemoglobinemia
* Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19...)
* Prone position

Primary outcomes:
measure: Diffence between Nellcor SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between FreeO2 SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between Nonin ear clip and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between Masimo SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between Philips SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between Contec SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
measure: Diffence between Bejing choice SpO2 and the SaO2 value
timeFrame: During arterial blood gase sample
Secondary outcomes:
measure: Overestimation and underestimation of SaO2
timeFrame: During arterial blood gase sample
measure: Hypoxemia detection
timeFrame: During arterial blood gase sample
measure: Hyperoxemia detection
timeFrame: During arterial blood gase sample
measure: Gaps between the different oximeters
timeFrame: During arterial blood gase sample
measure: Finger and ear sensor comparison
timeFrame: During arterial blood gase sample
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
References: