Recruiting

Oxygen Therapy

Sponsor:

Laval University

Code:

NCT06646991

Conditions

Oxygen Toxicity

COPD Bronchitis

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nasal canula - up to 6 liters per minute

Nasal canula - up to 15 liters per minute

Open oxygen mask

Simple oxygen face mask

Study Details

Brief 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).

Conditions

Oxygen Toxicity

COPD Bronchitis

Respiratory Failure

Study ID

NCT06646991

Start date

Nov 27, 2024

Status verified date

Nov, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Nellcor oximeter

other: Nonin Oximeter

Interventions

Nasal 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.

Nasal 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.

Open 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.

Simple 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

François Lellouche

1-418-656-8711françoislellouche@criucpq.ulaval.ca

Locations

Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

Francois Lellouche Principal Investigator

418-656-8711francois.lellouche@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Laval University on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.