Oxygen ToxicityOxygap pongNCT05590130
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
A study testing Manual Oxygen titration with Philips oximeter (SpO2 target 90%), Manual oxygen titration with Nonin oximeter (SpO2 target 90%) and Manual Oxygen titration with Philips oximeter (SpO2 target 94%) in people with Oxygen Toxicity and Respiratory Failure, run by Laval University at 1 site in Canada.
Trial summary
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Toxicity, Respiratory Failure
- What is being tested?
- Manual Oxygen titration with Philips oximeter (SpO2 target 90%), Manual oxygen titration with Nonin oximeter (SpO2 target 90%) and Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 16 Nov 2022to Dec 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Patients admitted to postoperative cardiac surgery intensive care unit
- Presence of an arterial catheter Specific for the extubate patient
- Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21
Who cannot join
- No SpO2 signal with oximeter in use
- False nails or nail polish
- Methemoglobinemia >0.015 on last available arterial gas
- Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
- Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
Francois Lellouche, francois.lellouche@criucpq.ulaval.ca
About this study
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
Read the detailed description
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
- Conditions
- Oxygen Toxicity, Respiratory Failure
- Being tested
- Manual Oxygen titration with Philips oximeter (SpO2 target 90%), Manual oxygen titration with Nonin oximeter (SpO2 target 90%), Manual Oxygen titration with Philips oximeter (SpO2 target 94%), Manual oxygen titration with Nonin oximeter (SpO2 target 94%)
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Oxygen titration with Philips oximeter (SpO2 target 90%)Device
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
Manual oxygen titration with Nonin oximeter (SpO2 target 90%)Device
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
Manual Oxygen titration with Philips oximeter (SpO2 target 94%)Device
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Manual oxygen titration with Nonin oximeter (SpO2 target 94%)Device
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
| Study group | Role | What they receive |
|---|---|---|
| Nonin oximeter with a 90% SpO2 target | Experimental | During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2. Receives: Device: Manual oxygen titration with Nonin oximeter (SpO2 target 90%) |
| Philips oximeter with a 90% SpO2 target | Experimental | During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2. Receives: Device: Manual Oxygen titration with Philips oximeter (SpO2 target 90%) |
| Nonin oximeter with a 94% SpO2 target | Experimental | During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2. Receives: Device: Manual oxygen titration with Nonin oximeter (SpO2 target 94%) |
| Philips oximeter with a 94% SpO2 target | Experimental | During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2. Receives: Device: Manual Oxygen titration with Philips oximeter (SpO2 target 94%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen flow (or FiO2)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
Measured: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Secondary outcomes (1)
Difference between SpO2 and SaO2
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)
Measured: assessed up to 10 minutes - at the same of the arterial blood gases punction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start16 Nov 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT05590130
- Sponsor's protocol ID
- 22266
- Acronym
- Oxygap pong
- Status last verified
- Nov 2026
- First submitted
- 14 Oct 2022
- 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 Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
- ClinicalTrials.gov ID
- NCT05590130
- Acronym / sponsor ID
- Oxygap pong / 22266
- Conditions
- Oxygen Toxicity, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2022 (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 investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
Detailed description
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nonin oximeter with a 90% SpO2 target | Experimental | Device: Manual oxygen titration with Nonin oximeter (SpO2 target 90%)During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2. |
| Philips oximeter with a 90% SpO2 target | Experimental | Device: Manual Oxygen titration with Philips oximeter (SpO2 target 90%)During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2. |
| Nonin oximeter with a 94% SpO2 target | Experimental | Device: Manual oxygen titration with Nonin oximeter (SpO2 target 94%)During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2. |
| Philips oximeter with a 94% SpO2 target | Experimental | Device: Manual Oxygen titration with Philips oximeter (SpO2 target 94%)During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Patients admitted to postoperative cardiac surgery intensive care unit
- Presence of an arterial catheter Specific for the extubate patient
- Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21
Key exclusion criteria (5 listed)
- No SpO2 signal with oximeter in use
- False nails or nail polish
- Methemoglobinemia >0.015 on last available arterial gas
- Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
- Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
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 |
|---|---|---|
| Manual Oxygen titration with Philips oximeter (SpO2 target 90%)Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter | Device | Philips oximeter with a 90% SpO2 target |
| Manual oxygen titration with Nonin oximeter (SpO2 target 90%)Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter | Device | Nonin oximeter with a 90% SpO2 target |
| Manual Oxygen titration with Philips oximeter (SpO2 target 94%)Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter | Device | Philips oximeter with a 94% SpO2 target |
| Manual oxygen titration with Nonin oximeter (SpO2 target 94%)Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter | Device | Nonin oximeter with a 94% SpO2 target |
Primary outcome
Oxygen flow (or FiO2)
Time frame: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
1 secondary outcome
Difference between SpO2 and SaO2
Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Oxygen titration with Philips oximeter (SpO2 target 90%), Manual oxygen titration with Nonin oximeter (SpO2 target 90%) and Manual Oxygen titration with Philips oximeter (SpO2 target 94%) in people with Oxygen Toxicity and Respiratory Failure, run by Laval University at 1 site in Canada.
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 5 inclusion and 5 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 1 site in Canada. 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?
Contact Francois Lellouche (418656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen flow (or FiO2) (time frame: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)). 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.