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

Recruiting

• Conditions: Hyperoxemia; Respiratory Failure; Hypoxemia

• Registration Number: NCT04772183
• Lead Sponsor: Laval University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-26
• Study Start: 2021-03-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHUM; 🇨🇦 Montréal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Quebec, Canada