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

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Conditions

Hypoxemia

Treatments

Device: Non-Rebreather mask
Device: Double-Trunk 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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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