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

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 Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Hypoxemia; Hyperoxemia
• Intervention / Treatment: Device: SpO2 and SaO2 comparison

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
    • Contact: Francois Lellouche; Email: francois.lellouche@criucpq.ulaval.ca
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • CHU Ste-Justine
      • Contact: Philippe Jouvet; Email: philippe.jouvet.med@ssss.gouv.qc.ca
      • Sub-Investigator: Michael Sauthier
    • Montréal, Quebec, Canada, H2X0A9
      • CHUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric population; Pediatric population < 18 years old (estimated 100 patients)	Device: SpO2 and SaO2 comparison; 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; Adult population >or= 18 years old (estimated 100 patients)	Device: SpO2 and SaO2 comparison; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overestimation and underestimation of SaO2	Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.	During procedure (arterial blood gas sample collection)
Hypoxemia detection	Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)	During procedure (arterial blood gas sample collection)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperoxemia detection	Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)	During procedure (arterial blood gas sample collection)
Gaps between the different oximeters	Average of the SpO2 value gaps between the different oximeters tested	During procedure (arterial blood gas sample collection)

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: 22373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No