NCT06102499 Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
| NCT ID | NCT06102499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-06-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Frequently Asked Questions
Who can join the NCT06102499 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06102499 currently recruiting?
Yes, NCT06102499 is actively recruiting participants. Visit ClinicalTrials.gov or contact Laval University to inquire about joining.
Where is the NCT06102499 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Québec, Canada.
Who is sponsoring the NCT06102499 clinical trial?
NCT06102499 is sponsored by Laval University. The trial plans to enroll 200 participants.