Respiratory FailureOxygap 2NCT06102499
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
An observational study of Respiratory Failure and Hypoxemia, run by Laval University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Respiratory Failure, Hypoxemia, Hyperoxemia
- What is being tested?
- SpO2 and SaO2 comparison
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesCanada
- Study dates
- 20 Jun 2024to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient in ICU with arterial catheter already installed will be consider
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X0A9
Emmanuel Charbonney, 514-890-8000, emmanuel.charbonney@umontreal.ca
- Not yet recruiting
CHU Ste-Justine
Montreal, Quebec, H3T 1C5
Philippe Jouvet, philippe.jouvet.med@ssss.gouv.qc.ca
Michael Sauthier
- Not yet recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Francois Lellouche, francois.lellouche@criucpq.ulaval.ca
About this study
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
- Respiratory Failure, Hypoxemia, Hyperoxemia
- Being tested
- SpO2 and SaO2 comparison
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 and SaO2 comparisonDevice
Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Pediatric population | Pediatric population < 18 years old (estimated 100 patients) Receives: Device: SpO2 and SaO2 comparison | |
| Adult population | Adult population >or= 18 years old (estimated 100 patients) Receives: Device: SpO2 and SaO2 comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between GE oximeter SpO2 and the SaO2 value
Measured: During procedure (arterial blood gas sample collection)
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Nellcor oximeter SpO2 and the SaO2 value
Measured: During procedure (arterial blood gassample collection)
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Masimo oximeter SpO2 and the SaO2 value
Measured: During procedure (arterial blood gas sample collection)
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Nonin oximeter SpO2 and the SaO2 value
Measured: During procedure (arterial blood gas sample collection)
Secondary outcomes (2)
Overestimation and underestimation of SaO2
Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.
Measured: During procedure (arterial blood gas sample collection)
Hypoxemia detection
Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)
Measured: During procedure (arterial blood gas sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102499
- Sponsor's protocol ID
- 22373
- Acronym
- Oxygap 2
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No