Comparing different oximeters for measuring oxygen levels in ICU patients
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
This study is testing how accurately different oximeters measure oxygen levels in ICU patients to see which ones give the best readings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT06102499 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of various oximeters in measuring oxygen saturation (SpO2) compared to arterial saturation (SaO2) in intensive care patients. By analyzing the performance of devices from General Electric, Medtronic, Masimo, and Nonin, the study seeks to identify systematic biases and precision differences among these oximeters. The findings will help refine current recommendations for optimal oxygen therapy, addressing the variability in oximeter readings that can impact patient care. The study focuses on adult patients with an arterial catheter already installed in an ICU setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older who are admitted to the Intensive Care Unit with an arterial catheter in place.
Not a fit: Patients who may not benefit from this study include those with poor signal quality from pulse oximeters, severe shock states, or specific conditions like methemoglobinemia.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in oxygen monitoring, enhancing patient safety and treatment outcomes in critical care.
How similar studies have performed: Other studies have shown varying results in the accuracy of different oximeters, indicating that this approach is relevant and necessary for improving clinical practices.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec and 2 other locations
- Chum — Montreal, Quebec, Canada (Recruiting)
- CHU Ste-Justine — Montreal, Quebec, Canada (Not_yet_recruiting)
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.