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 5 sites in 3 countries.
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
- 250 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 20 Jun 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Canada3 sites, 2 recruiting
- Completed
CHUM
Montreal, Quebec, H2X0A9
- Recruiting
CHU Ste-Justine
Montreal, Quebec, H3T 1C5
Michael Sauthier, 514 345-4931, Michael.Sauthier.med@ssss.gouv.qc.ca
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Francois Lellouche, 1-418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca
Guadeloupe1 site, 1 recruiting
- Not yet recruiting
CHU de la Guadeloupe
Les Abymes, 97139
Frederic Martino, : +590 590 89 11 32, frederic.martino@chu-guadeloupe.fr
Tunisia1 site, 1 recruiting
- Not yet recruiting
Hôpital Universitaire Farhat Hached,
Sousse, 4000
Mohamed Boussarsar, +216 73 102 500, hamadi.boussarsar@gmail.com
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 150 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 2027 (estimated)
- Study completion30 Dec 2027 (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.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- 250 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
- Nov 2026
- First submitted
- 6 Oct 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
- ClinicalTrials.gov ID
- NCT06102499
- Acronym / sponsor ID
- Oxygap 2 / 22373
- Conditions
- Respiratory Failure, Hypoxemia, Hyperoxemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric population | – | Device: SpO2 and SaO2 comparisonPediatric population < 18 years old (estimated 100 patients) |
| Adult population | – | Device: SpO2 and SaO2 comparisonAdult population >or= 18 years old (estimated 150 patients) |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient in ICU with arterial catheter already installed will be consider
Key inclusion criteria (7 listed)
- ≥ 18 years old (adult population) -
- Patients admitted to the Intensive Care Unit
- Artery catheter already installed
- Pediatric population
- Below 18 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpO2 and SaO2 comparisonSeveral pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded | Device | Adult population, Pediatric population |
Primary outcome
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
Time frame: During procedure (arterial blood gas sample collection)
Difference between GE oximeter SpO2 and the SaO2 value
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Time frame: During procedure (arterial blood gassample collection)
Difference between Nellcor oximeter SpO2 and the SaO2 value
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
Time frame: During procedure (arterial blood gas sample collection)
Difference between Masimo oximeter SpO2 and the SaO2 value
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
Time frame: During procedure (arterial blood gas sample collection)
Difference between Nonin oximeter SpO2 and the SaO2 value
2 secondary outcomes
Overestimation and underestimation of SaO2
Time frame: During procedure (arterial blood gas sample collection)
Hypoxemia detection
Time frame: During procedure (arterial blood gas sample collection)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Canada
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Hypoxemia, run by Laval University at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Guadeloupe, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases (time frame: During procedure (arterial blood gas sample collection)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.