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Clinical Trials in Canada / NCT06646991
Starting soon Not applicable

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

NCT06646991 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2024-12
Last updated
2024-11-22

Condition(s) studied

Oxygen ToxicityCOPD BronchitisRespiratory Failure

Investigational drug(s) / intervention(s)

Nasal canula - up to 6 liters per minuteNasal canula - up to 15 liters per minuteOpen oxygen maskSimple oxygen face mask

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.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institut Universitaire de Cardiologie et de Pneumologie de Québec Québec Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06646991 on ClinicalTrials.gov ↗ ← All trials in Canada