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

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Double-Trunk Mask
Non-Rebreather mask
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cliniques universitaires Saint-Luc
  • Epicura
  • Centre Hospitalier Universitaire de Tivoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double-Trunk Mask

Non-Rebreather Mask

Arm Description

The oxygen delivery system is the DTM

The oxygen delivery system is the NRM

Outcomes

Primary Outcome Measures

Changes in PaO2
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Secondary Outcome Measures

Changes in PaCO2
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system
Changes in pH
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Changes in respiratory rate
Respiratory rate is measured during one minute by visual inspection.
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
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

Full Information

First Posted
May 7, 2020
Last Updated
February 6, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04383821
Brief Title
Comparison of the Non-rebreather Mask With the Double-trunk Mask
Official Title
Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-Trunk Mask
Arm Type
Experimental
Arm Description
The oxygen delivery system is the DTM
Arm Title
Non-Rebreather Mask
Arm Type
Active Comparator
Arm Description
The oxygen delivery system is the NRM
Intervention Type
Device
Intervention Name(s)
Double-Trunk Mask
Intervention Description
The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
Intervention Type
Device
Intervention Name(s)
Non-Rebreather mask
Intervention Description
The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.
Primary Outcome Measure Information:
Title
Changes in PaO2
Description
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Time Frame
At baseline and 30 minutes after wearing DTM
Secondary Outcome Measure Information:
Title
Changes in PaCO2
Description
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system
Time Frame
At baseline and 30 minutes after wearing DTM
Title
Changes in pH
Description
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Time Frame
At baseline and 30 minutes after wearing DTM
Title
Changes in respiratory rate
Description
Respiratory rate is measured during one minute by visual inspection.
Time Frame
At baseline and 30 minutes after wearing both systems
Title
Comfort with the oxygen delivery systems
Description
A Likert scale from -5 to +5 will be used to measure the subjective comfort of the patient while wearing both oxygen delivery systems
Time Frame
30 minutes after wearing both systems
Title
Dyspnea with the oxygen delivery systems
Description
A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems
Time Frame
30 minutes after wearing both systems

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Epicura
City
Hornu
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Tivoli
City
La Louvière
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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