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Not yet recruiting NCT06646991

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

No phase Interventional Oxygen Toxicity COPD Bronchitis Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal canula - up to 6 liters per minute, Nasal canula - up to 15 liters per minute, Open oxygen mask, Simple oxygen face mask.
Who it may be relevant to
Registry conditions: Oxygen Toxicity, COPD Bronchitis, Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • Device 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 ±
  • Device 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.
  • Device 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.
  • Device 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 measures

  • Oxygen flow [Time frame: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec

Identifiers

NCT: NCT06646991 · 2025-4198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗