ClinicalTrials.gg
RecruitingNCT06646991InterfacesUpdated Nov 5, 2026

Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates

An interventional study of Nasal canula - up to 6 liters per minute and Nasal canula - up to 15 liters per minute in Oxygen Toxicity, COPD Bronchitis and Respiratory Failure, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Laval University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Updated Nov 5, 2026Now RecruitingStart date moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies in Respiratory Insufficiency with a site in Canada — 24 open to participants now, 29 under way, 1 of them phase 3. Respiratory Insufficiency · Canada.

Planned enrollment
45th of 66
20 · median 31
Started
2024
with 6 others
No phase
46 of 94
10 open now
Primary completion
2027-06
later than 21 of 28 live
Registered
84th of 94
by date
Lead sponsor
8 of 94
Laval University

Among the 94 studies in Respiratory Insufficiency with a site in Canada, this one is the 45th largest by planned enrollment of the 66 interventional ones that give a count, is one of 7 that started in 2024, is one of 46 with no phase, reaches primary completion later than 21 of the 28 other live ones, and was the 84th registered.

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

Browse Respiratory Insufficiency studies →

Open to participants now

24 of the 94 studies in Respiratory Insufficiency with a site in Canada are open now. Recruiting first, the newest first:

18 more — sign in →

All 24 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 178 Respiratory Insufficiency studies recruiting now, 134 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 19 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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).

03

Conditions studied

  • Oxygen Toxicity
  • COPD Bronchitis
  • Respiratory Failure
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • No SpO2 signal with with the usual oximeter
  • False nails or nail polish
  • Severe anemia documented on last blood count during current hospitalization ( (Hb) \< 80g/L)
  • Oxygen flow > 6 L/min
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Nellcor oximeter

    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

  • Other
    Nonin Oximeter

    Device: Nasal canula - up to 6 liters per minute

Interventions

  • DeviceNasal canula - up to 6 liters per minute

    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.

  • DeviceNasal canula - up to 15 liters per minute

    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.

  • DeviceOpen oxygen mask

    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.

  • DeviceSimple oxygen face mask

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)

Secondary outcomes

  1. Partial oxygen weaning

    Rate of partial oxygen weaning (Oxygen flow \<=0.5 L/min)

    Time frame: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

  2. Complete oxygen weaning

    Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)

    Time frame: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

Other outcomes

  1. Gaps between the different oximeters

    Average of the SpO2 value gaps between the different oximeters tested

    Time frame: through period completion, minute 15

  2. Gaps between PaCO2

    PaCO2 value at the end of the period

    Time frame: through period completion, minute 15

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Jun 2027, 31 months after the start.

Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 31 months is above that.

Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Dec 2024 → Nov 2024, primary completion Jun 2025 → Jun 2027 and completion Dec 2025 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2024
First posted
Oct 17, 2024
StartActual
Nov 27, 2024was Dec 2024
Primary completionEst.
Jun 2027was Jun 2025
CompletionEst.
Dec 2027was Dec 2025
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 5, 2026
Sites
1 site added, 1 site removed
Show site
  • Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval · Québec, Canada
Show 1 removed
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec · Quebec, Canada
Nov 5, 2026
Start date
Dec 2024→Nov 27, 2024 (actual)
Nov 5, 2026
Primary completion
Jun 2025→Jun 2027
Nov 5, 2026
Study completion
Dec 2025→Dec 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Recruiting
    1 site added, 1 site removed
    Show site
    • Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval · Québec, Canada
    Show 1 removed
    • Institut Universitaire de Cardiologie et de Pneumologie de Québec · Quebec, Canada
    Start date Dec 2024→Nov 27, 2024 (now actual)
    Primary completion Jun 2025→Jun 2027
    Study completion Dec 2025→Dec 2027
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06646991
Lead sponsor
Laval University
Responsible party
François Lellouche (Principal Investigator, Laval University) — Principal investigator
First posted
Oct 17, 2024
Start date
Nov 27, 2024
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

François Lellouche
Contact
françoislellouche@criucpq.ulaval.ca
1-418-656-8711

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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