Comparison of the Non-rebreather Mask With the Double-trunk Mask

Not Applicable

Completed

• Conditions: Hypoxemia

• Registration Number: NCT04383821
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.

Detailed Description

The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2020-05-15
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-06
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Acute hypoxemia not corrected with nasal cannula

Exclusion Criteria

• Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
• Confusion
• Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in PaO2	At baseline and 30 minutes after wearing DTM	Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Secondary Outcome Measures

Name	Time	Method
Dyspnea with the oxygen delivery systems	30 minutes after wearing both systems	A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems
Changes in PaCO2	At baseline and 30 minutes after wearing DTM	Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system
Changes in respiratory rate	At baseline and 30 minutes after wearing both systems	Respiratory rate is measured during one minute by visual inspection.
Changes in pH	At baseline and 30 minutes after wearing DTM	Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Comfort with the oxygen delivery systems	30 minutes after wearing both systems	A Likert scale from -5 to +5 will be used to measure the subjective comfort of the patient while wearing both oxygen delivery systems

Trial Locations

Locations (3)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Brussels Capital, Belgium

Epicura; 🇧🇪 Hornu, Belgium

Centre Hospitalier Universitaire de Tivoli; 🇧🇪 La Louvière, Belgium