Actively Recruiting

Age: 0Years - 100Years
All Genders
NCT06102499

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

Led by Laval University · Updated on 2025-08-28

200

Participants Needed

3

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older (adult population)
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed
  • Below 18 years old (pediatric population)
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed
Not Eligible

You will not qualify if you...

  • No or poor signal with the usual pulse oximeter based on clinician judgment
  • High dose of vasopressors or inotropes (epinephrine or norepinephrine 4 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
  • Pigmented nails or nail polish
  • History of methemoglobinemia
  • Hemoglobin below 80 g/L
  • Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2)
  • Prone position
  • Use of Extra Corporeal Membrane Oxygenator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

CHUM

Montreal, Quebec, Canada, H2X0A9

Actively Recruiting

2

CHU Ste-Justine

Montreal, Quebec, Canada, H3T 1C5

Not Yet Recruiting

3

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5

Not Yet Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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