Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study (Oxygap 2)

Laval University

Status: Enrolling

Conditions: Respiratory Failure; Hyperoxemia; Hypoxemia

Treatments: Device: SpO2 and SaO2 comparison

Study type: Observational

Funder types: Other

Identifiers

NCT06102499

22373

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

Pediatric population

Description:

Pediatric population \< 18 years old (estimated 100 patients)

Treatment:

Device: SpO2 and SaO2 comparison

Adult population

Description:

Adult population \>or= 18 years old (estimated 100 patients)

Treatment:

Device: SpO2 and SaO2 comparison