Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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