Actively Recruiting

Age: 0Years - 100Years
All Genders
ID06102499

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

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the accuracy of different pulse oximeters in measuring blood oxygen levels in intensive care patients receiving oxygen therapy. The study compares SpO2 values from four oximeters (General Electric-GE, Medtronic, Masimo, and Nonin) with the arterial oxygen saturation (SaO2) reference obtained from arterial blood gas samples. This research aims to improve oxygen therapy recommendations by addressing variability in oximeter readings. The study involves placing several pulse oximeters on patients a few minutes before collecting arterial blood gases. SpO2 readings from each device are recorded simultaneously with the arterial blood sample. The study includes both pediatric (under 18 years) and adult (18 years and older) populations admitted to intensive care units with artery catheters already installed. Participants will be monitored during arterial blood gas sample collection, where differences between each oximeter's SpO2 value and the SaO2 reference are measured. Researchers will assess overestimation, underestimation, and hypoxemia detection capabilities of each device. The study will continue until December 2026, with data helping to refine optimal oxygenation guidelines for intensive care patients.

CONDITIONS

Brief 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...

  • Adult participants 18 years or older admitted to the Intensive Care Unit with an artery catheter already installed
  • Pediatric participants under 18 years old admitted to the Intensive Care Unit with an artery catheter already installed
Not Eligible

You will not qualify if you...

  • No or poor pulse oximeter signal based on clinician judgment
  • Receiving high doses of vasopressors or inotropes (epinephrine or norepinephrine c3 1mcg/kg/min) or in shock state (lactates above 3 mmoles/L)
  • Presence of pigmented nails or nail polish
  • History of methemoglobinemia
  • Hemoglobin level below 80 g/L
  • Patient in isolation for infections (multi-resistant bacteria, C-Difficile, SARS-COV-2, etc.)
  • Patient in prone position or on Extra Corporeal Membrane Oxygenator (ECMO)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - During arterial blood gas sample collection

Participants admitted to the Intensive Care Unit with an artery catheter have several pulse oximeters placed shortly before an arterial blood gas sample is taken to compare SpO2 values with arterial saturation.

1 visit (in-person)

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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