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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain12 enrolled

Overview

This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

COVID Hypoxemia

Interventions

Standard interfaceOTHER

The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.

Double-Trunk MaskDEVICE

The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Change in O2 output

The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.

Time frame: At baseline and 30 minutes after wearing both systems

Secondary Outcomes

Comfort with the interfaces

A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM

Time frame: 30 minutes after wearing both systems

Changes in PaO2

Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Time frame: At baseline and 30 minutes after wearing DTM

Changes in PaCO2

Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.

Time frame: At baseline and 30 minutes after wearing DTM

Changes in pH

Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.

Time frame: At baseline and 30 minutes after wearing DTM

Changes in respiratory rate

Respiratory rate is measured during one minute by visual inspection.

Time frame: At baseline and 30 minutes after wearing both systems

Data from ClinicalTrials.gov

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