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NCT04383821 Clinical Trial

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

Hypoxemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04383821
Other study ID # DTM-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2020
Est. completion date July 1, 2021

Study information
Verified date February 2022
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Double-Trunk Mask
The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
• Non-Rebreather mask
The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels Brussels Capital
Belgium Epicura Hornu
Belgium Centre Hospitalier Universitaire de Tivoli La Louvière

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Changes in respiratory rate Respiratory rate is measured during one minute by visual inspection. At baseline and 30 minutes after wearing both systems
Secondary 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
Secondary 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
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