Oxygen DeliveryNCT07168213
Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy
A study testing Manual FiO2 titration with Philips oximeter (SpO2 target 90%), Manual FiO2 titration with Nonin oximeter (SpO2 target 90%) and Manual FiO2 titration with Philips oximeter (SpO2 target 94%) in people with Oxygen Delivery and Acute Respiratory Failure, run by Laval University at 1 site in Canada.
Trial summary
Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Delivery, Acute Respiratory Failure, High Flow Oxygen Therapy
- What is being tested?
- Manual FiO2 titration with Philips oximeter (SpO2 target 90%), Manual FiO2 titration with Nonin oximeter (SpO2 target 90%) and Manual FiO2 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2025to 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
- Admiitted in intensive care unit
- Presence of an arterial catheter
- Ongoing on high flow nasal oxygen therapy with SpO2 between 88 and 100% with a FiO2 between 40 and 80% with the usual oximeter .
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 ...)
- Expected to use another respiratory support within two hour of inclusion (NIV or mechanical ventilation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francois Lellouche Principal Investigator contact
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V4G5
Francois Lellouche, 418-656-8711, francois.lellouche@criucpq.ulaval.ca
About this study
Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.
Read the detailed description
The oximeters evaluated will be the Nonin (Plymouth, MN) and the Philips (Eindhoven, Netherlands). Two SpO2 targets will be evaluated: 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.
- Conditions
- Oxygen Delivery, Acute Respiratory Failure, High Flow Oxygen Therapy, Hypoxemic Acute Respiratory Failure
- Being tested
- Manual FiO2 titration with Philips oximeter (SpO2 target 90%), Manual FiO2 titration with Nonin oximeter (SpO2 target 90%), Manual FiO2 titration with Philips oximeter (SpO2 target 94%), Manual FiO2 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 FiO2 titration with Philips oximeter (SpO2 target 90%)Device
FiO2 titration to reach the SpO2 target (set at 90%) with Philips oximeter
Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)Device
FiO2 titration to reach the SpO2 target (set at 90%) with Nonin oximeter
Manual FiO2 titration with Philips oximeter (SpO2 target 94%)Device
FiO2 titration to reach the SpO2 target (set at 94%) with Philips oximeter
Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)Device
FiO2 titration to reach the SpO2 target (set at 94%) with Nonin oximeter
| Study group | Role | What they receive |
|---|---|---|
| Nonin oximeter with a 90% SpO2 target | Experimental | During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2. Receives: Device: Manual FiO2 titration with Nonin oximeter (SpO2 target 90%) |
| Philips oximeter with a 90% SpO2 target | Experimental | During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2. Receives: Device: Manual FiO2 titration with Philips oximeter (SpO2 target 90%) |
| Nonin oximeter with a 94% SpO2 target | Experimental | During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2. Receives: Device: Manual FiO2 titration with Nonin oximeter (SpO2 target 94%) |
| Philips oximeter with a 94% SpO2 target | Experimental | During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2. Receives: Device: Manual FiO2 titration with Philips oximeter (SpO2 target 94%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FiO2
FiO2 at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
Measured: Mean FiO2 in the two last minute of each study period between minute 8 and 10
Secondary outcomes (5)
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
High flow weaning criteria
Percentage of patient whose average FiO2 level below 40%
Measured: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Intensive care unit transfert criteria
Percentage of patients whose average FiO2 level over 60%
Measured: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Intubation criteria
Percentage of patients whose average FiO2 level over 80%
Measured: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Mean difference on oxymeter
Mean (±SD) of the gaps between the different oximeters tested
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 posted11 Sep 2025
- Study start21 Oct 2025
- 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 DeliveryStudies 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
- 30 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
- NCT07168213
- Sponsor's protocol ID
- 2026-4432
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2025
- Last updated
- 9 Mar 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy
- ClinicalTrials.gov ID
- NCT07168213
- Acronym / sponsor ID
- 2026-4432
- Conditions
- Oxygen Delivery, Acute Respiratory Failure, High Flow Oxygen Therapy, Hypoxemic Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (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.
Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.
Detailed description
The oximeters evaluated will be the Nonin (Plymouth, MN) and the Philips (Eindhoven, Netherlands). Two SpO2 targets will be evaluated: 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.
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 FiO2 titration with Nonin oximeter (SpO2 target 90%)During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2. |
| Philips oximeter with a 90% SpO2 target | Experimental | Device: Manual FiO2 titration with Philips oximeter (SpO2 target 90%)During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2. |
| Nonin oximeter with a 94% SpO2 target | Experimental | Device: Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2. |
| Philips oximeter with a 94% SpO2 target | Experimental | Device: Manual FiO2 titration with Philips oximeter (SpO2 target 94%)During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration 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 (4 listed)
- ≥ 18 years of age
- Admiitted in intensive care unit
- Presence of an arterial catheter
- Ongoing on high flow nasal oxygen therapy with SpO2 between 88 and 100% with a FiO2 between 40 and 80% with the usual oximeter .
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 ...)
- Expected to use another respiratory support within two hour of inclusion (NIV or mechanical ventilation)
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 FiO2 titration with Philips oximeter (SpO2 target 90%)FiO2 titration to reach the SpO2 target (set at 90%) with Philips oximeter | Device | Philips oximeter with a 90% SpO2 target |
| Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)FiO2 titration to reach the SpO2 target (set at 90%) with Nonin oximeter | Device | Nonin oximeter with a 90% SpO2 target |
| Manual FiO2 titration with Philips oximeter (SpO2 target 94%)FiO2 titration to reach the SpO2 target (set at 94%) with Philips oximeter | Device | Philips oximeter with a 94% SpO2 target |
| Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)FiO2 titration to reach the SpO2 target (set at 94%) with Nonin oximeter | Device | Nonin oximeter with a 94% SpO2 target |
Primary outcome
FiO2
Time frame: Mean FiO2 in the two last minute of each study period between minute 8 and 10
FiO2 at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
5 secondary outcomes
Difference between SpO2 and SaO2
Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction
High flow weaning criteria
Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Intensive care unit transfert criteria
Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Intubation criteria
Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)
Mean difference on oxymeter
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 9 Mar 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.
Francois Lellouche Principal Investigator contact
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 FiO2 titration with Philips oximeter (SpO2 target 90%), Manual FiO2 titration with Nonin oximeter (SpO2 target 90%) and Manual FiO2 titration with Philips oximeter (SpO2 target 94%) in people with Oxygen Delivery and Acute 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 4 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 9 Mar 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 Principal Investigator (418-656-8711 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?
FiO2 (time frame: Mean FiO2 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 9 Mar 2026.