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

Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Double-Trunk Mask; Device: Non-Rebreather mask

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hornu, Belgium
    • Epicura
  • La Louvière, Belgium
    • Centre Hospitalier Universitaire de Tivoli
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double-Trunk Mask; The oxygen delivery system is the DTM	Device: Double-Trunk Mask; The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
Active Comparator: Non-Rebreather Mask; The oxygen delivery system is the NRM	Device: Non-Rebreather mask; The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: DTM-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No