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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06646991
Acronym
Interfaces
Enrollment
20
Registered
2024-10-17
Start date
2024-12-31
Completion date
2025-12-31
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Bronchitis, Oxygen Toxicity, Respiratory Failure

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).

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.

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Oxygen flowMean 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

Secondary

MeasureTime frameDescription
Partial oxygen weaningMean oxygen flow in the five last minute of each study period (between minute 10 and 15)Rate of partial oxygen weaning (Oxygen flow \<=0.5 L/min)
Complete oxygen weaningMean oxygen flow in the five last minute of each study period (between minute 10 and 15)Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)

Other

MeasureTime frameDescription
Gaps between the different oximetersthrough period completion, minute 15Average of the SpO2 value gaps between the different oximeters tested
Gaps between PaCO2through period completion, minute 15PaCO2 value at the end of the period

Countries

Canada

Contacts

Primary ContactFrançois Lellouche
françoislellouche@criucpq.ulaval.ca1-418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026