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
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

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