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

Respiratory Failure Clinical Trial

— Oxygap 2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102499
• Other study ID #: 22373
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: n/a
• 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 (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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

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	CHU Ste-Justine	Montréal	Quebec
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
Other	Hyperoxemia detection	Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)	During procedure (arterial blood gas sample collection)
Other	Gaps between the different oximeters	Average of the SpO2 value gaps between the different oximeters tested	During procedure (arterial blood gas sample collection)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Overestimation and underestimation of SaO2	Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.	During procedure (arterial blood gas sample collection)
Secondary	Hypoxemia detection	Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)	During procedure (arterial blood gas sample collection)