OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase (OxyGap)

OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Hypoxemia; Hyperoxemia
• Intervention / Treatment: Device: SpO2 and SaO2 comparison

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V4G5
    • Recruiting
    • Institut universitaire de Cardiologie et de Pneumologie de Quebec
  • Quebec
    • Montréal, Quebec, Canada, H2X0A9
      • Not yet recruiting
      • CHUM
      • Contact: Emmanuel Charbonney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffence between Nellcor SpO2 and the SaO2 value	Diffence between Nellcor oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between FreeO2 SpO2 and the SaO2 value	Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between Nonin ear clip and the SaO2 value	Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between Masimo SpO2 and the SaO2 value	Diffence between Masimo oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between Philips SpO2 and the SaO2 value	Diffence between Philips oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between Contec SpO2 and the SaO2 value	Difffence between Contec oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Diffence between Bejing choice SpO2 and the SaO2 value	Diffence between Bejing choice oximeter SpO2 and the SaO2 value	During arterial blood gase sample

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overestimation and underestimation of SaO2	% of pairs with overestimation and underestimation of SaO2 for each oximeter.	During arterial blood gase sample
Hypoxemia detection	Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)	During arterial blood gase sample
Hyperoxemia detection	Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)	During arterial blood gase sample
Gaps between the different oximeters	Average of the SpO2 value gaps between the different oximeters tested	During arterial blood gase sample
Finger and ear sensor comparison	Comparison of the finger sensor and ear clip sensor for Nonin oximeter	During arterial blood gase sample

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 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: 2021-3624

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