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

NCT06646991 | Not Yet Recruiting

• 1 other identifier: 2025-4198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oxygen flow

  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

  Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)

Secondary Outcomes (2)

• Partial oxygen weaning

  Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

• Complete oxygen weaning

  Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

Other Outcomes (2)

• Gaps between the different oximeters

  through period completion, minute 15

• Gaps between PaCO2

  through period completion, minute 15

Study Arms (2)

Nellcor oximeter

OTHER

Device: Nasal canula - up to 6 liters per minute; Device: Nasal canula - up to 15 liters per minute; Device: Open oxygen mask; Device: Simple oxygen face mask

Nonin Oximeter

OTHER

Device: Nasal canula - up to 6 liters per minute

Interventions

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.

Nellcor oximeter; Nonin Oximeter

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.

Nellcor oximeter

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.

Nellcor oximeter

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.

Nellcor oximeter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

François Lellouche

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)