Oxygen ToxicityInterfacesNCT06646991
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
A study testing Nasal canula - up to 6 liters per minute, Nasal canula - up to 15 liters per minute and Open oxygen mask in people with Oxygen Toxicity and COPD Bronchitis, run by Laval University at 1 site in Canada.
Trial summary
Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Toxicity, COPD Bronchitis, Respiratory Failure
- What is being tested?
- Nasal canula - up to 6 liters per minute, Nasal canula - up to 15 liters per minute and Open oxygen mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2024to 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
- Adult (> or = 18 years old)
- Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
- SpO2 < 92% ambient air with the usual oximeter
Who cannot join
- No SpO2 signal with with the usual oximeter
- False nails or nail polish
- Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)
- Oxygen flow > 6 L/min
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
Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
Québec, Quebec, G1V4G5
Francois Lellouche Principal Investigator, 418-656-8711, francois.lellouche@criucpq.ulaval.ca
About this study
Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .
The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).
secondary objective).
- Conditions
- Oxygen Toxicity, COPD Bronchitis, Respiratory Failure
- Being tested
- Nasal canula - up to 6 liters per minute, Nasal canula - up to 15 liters per minute, Open oxygen mask, Simple oxygen face mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal canula - up to 6 liters per minuteDevice
Oxygen will be administered via nasal cannula up to 6 liters per minute during this period.
Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient).
The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.
Nasal canula - up to 15 liters per minuteDevice
Oxygen will be administered via nasal cannula up to 15 liters per minute during this period.
Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).
The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.
Open oxygen maskDevice
Oxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).
The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.
Simple oxygen face maskDevice
Oxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).
The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.
| Study group | Role | What they receive |
|---|---|---|
| Nellcor oximeter | Other | Not described Receives: Device: Nasal canula - up to 6 liters per minute; Device: Nasal canula - up to 15 liters per minute; Device: Open oxygen mask; Device: Simple oxygen face mask |
| Nonin Oximeter | Other | Not described Receives: Device: Nasal canula - up to 6 liters per minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen flow
Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces
Measured: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
Secondary outcomes (2)
Partial oxygen weaning
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min)
Measured: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
Complete oxygen weaning
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)
Measured: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start27 Nov 2024
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06646991
- Sponsor's protocol ID
- 2025-4198
- Acronym
- Interfaces
- Status last verified
- Nov 2026
- First submitted
- 17 Jun 2024
- 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 Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
- ClinicalTrials.gov ID
- NCT06646991
- Acronym / sponsor ID
- Interfaces / 2025-4198
- Conditions
- Oxygen Toxicity, COPD Bronchitis, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Oct 2024 (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.
Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .
The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).
secondary objective).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nellcor oximeter | Other | Device: Nasal canula - up to 6 liters per minute, Device: Nasal canula - up to 15 liters per minute, Device: Open oxygen mask, Device: Simple oxygen face mask |
| Nonin Oximeter | Other | Device: Nasal canula - up to 6 liters per minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (> or = 18 years old)
- Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
- SpO2 < 92% ambient air with the usual oximeter
Key exclusion criteria (4 listed)
- No SpO2 signal with with the usual oximeter
- False nails or nail polish
- Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)
- Oxygen flow > 6 L/min
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 |
|---|---|---|
| Nasal canula - up to 6 liters per minuteOxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. | Device | Nellcor oximeter, Nonin Oximeter |
| Nasal canula - up to 15 liters per minuteOxygen will be administered via nasal cannula up to 15 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. | Device | Nellcor oximeter |
| Open oxygen maskOxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. | Device | Nellcor oximeter |
| Simple oxygen face maskOxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. | Device | Nellcor oximeter |
Primary outcome
Oxygen flow
Time frame: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces
2 secondary outcomes
Partial oxygen weaning
Time frame: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
Complete oxygen weaning
Time frame: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
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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Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
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Oxygen Toxicity: Mechanisms in Humans
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Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity
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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 Nasal canula - up to 6 liters per minute, Nasal canula - up to 15 liters per minute and Open oxygen mask in people with Oxygen Toxicity and COPD Bronchitis, 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 3 inclusion and 4 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 François Lellouche (1-418-656-8711, françoislellouche@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 (time frame: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)). 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.