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

Respiratory Failure Clinical Trial

— OxyGap  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772183
• Other study ID #: 2021-3624
• Status: Recruiting
• Start date: March 24, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: François Lellouche
• Phone: 418-656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxemia
• Hypoxemia
• Hypoxia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffence between Nellcor SpO2 and the SaO2 value	Diffence between Nellcor oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Primary	Diffence between FreeO2 SpO2 and the SaO2 value	Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Primary	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
Primary	Diffence between Masimo SpO2 and the SaO2 value	Diffence between Masimo oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Primary	Diffence between Philips SpO2 and the SaO2 value	Diffence between Philips oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Primary	Diffence between Contec SpO2 and the SaO2 value	Difffence between Contec oximeter SpO2 and the SaO2 value	During arterial blood gase sample
Primary	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	Overestimation and underestimation of SaO2	% of pairs with overestimation and underestimation of SaO2 for each oximeter.	During arterial blood gase sample
Secondary	Hypoxemia detection	Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)	During arterial blood gase sample
Secondary	Hyperoxemia detection	Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)	During arterial blood gase sample
Secondary	Gaps between the different oximeters	Average of the SpO2 value gaps between the different oximeters tested	During arterial blood gase sample
Secondary	Finger and ear sensor comparison	Comparison of the finger sensor and ear clip sensor for Nonin oximeter	During arterial blood gase sample