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

NCT06102499 | Recruiting

• 1 other identifier: 22373
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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

Conditions

Respiratory Failure; Hypoxemia; Hyperoxemia

Outcome Measures

Primary Outcomes (4)

• Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases

  Difference between GE oximeter SpO2 and the SaO2 value

  During procedure (arterial blood gas sample collection)

• Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases

  Difference between Nellcor oximeter SpO2 and the SaO2 value

  During procedure (arterial blood gassample collection)

• Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases

  Difference between Masimo oximeter SpO2 and the SaO2 value

  During procedure (arterial blood gas sample collection)

• Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases

  Difference between Nonin oximeter SpO2 and the SaO2 value

  During procedure (arterial blood gas sample collection)

Secondary Outcomes (2)

• Overestimation and underestimation of SaO2

  During procedure (arterial blood gas sample collection)

• Hypoxemia detection

  During procedure (arterial blood gas sample collection)

Other Outcomes (2)

• Hyperoxemia detection

  During procedure (arterial blood gas sample collection)

• Gaps between the different oximeters

  During procedure (arterial blood gas sample collection)

Study Arms (2)

Pediatric population

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

Device: SpO2 and SaO2 comparison

Adult population

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

Device: SpO2 and SaO2 comparison

Interventions

SpO2 and SaO2 comparison DEVICE

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; Pediatric population

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient in ICU with arterial catheter already installed will be consider

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (3)

CHUM

Montreal, Quebec, H2X0A9, Canada

RECRUITING

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 26, 2023
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)