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NCT Number: NCT06646991

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

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).

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Key information

Conditions

Oxygen Toxicity COPD Bronchitis Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal canula - up to 6 liters per minute

Device

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

Device

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

Device

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

Device

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 outcomes

  1. Oxygen flow

    Time frame: Mean 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 outcomes

  1. Partial oxygen weaning

    Time frame: Mean 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)

  2. Complete oxygen weaning

    Time frame: Mean 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 outcomes

  1. Gaps between the different oximeters

    Time frame: through period completion, minute 15

    Average of the SpO2 value gaps between the different oximeters tested

  2. Gaps between PaCO2

    Time frame: through period completion, minute 15

    PaCO2 value at the end of the period

Study contacts

Contact information is provided by the study sponsor or research team.

François Lellouche

CONTACT

franç[email protected]

1-418-656-8711

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: Interfaces

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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