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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Hypoxemia

Treatments: Device: Double-Trunk Mask; Device: Non-Rebreather mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04383821

DTM-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Double-Trunk Mask

Experimental group

Description:

The oxygen delivery system is the DTM

Treatment:

Device: Double-Trunk Mask

Non-Rebreather Mask

Active Comparator group

Description:

The oxygen delivery system is the NRM

Treatment:

Device: Non-Rebreather mask