Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: COVID; Hypoxemia

Treatments: Other: Standard interface; Device: Double-Trunk Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04346420

DTM-001

Details and patient eligibility

About

This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in 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 standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COVID-19
• SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min).

Exclusion criteria

• Chronic obstructive pulmonary disease or other chronic respiratory disease
• Confusion
• Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
• 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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12 participants in 2 patient groups

O2 DTM+

Experimental group

Description:

The standard nasal cannula interface is accompanied with the DTM

Treatment:

Device: Double-Trunk Mask

O2 DTM-

Active Comparator group

Description:

The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM

Treatment:

Other: Standard interface