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Completed

NCT Number: NCT04346420

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

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

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Key information

Conditions

COVID Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard interface

Other

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 Mask

Device

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%.

Primary outcomes

  1. Change in O2 output

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

    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.

Secondary outcomes

  1. Comfort with the interfaces

    Time frame: 30 minutes after wearing both systems

    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

  2. Changes in PaO2

    Time frame: At baseline and 30 minutes after wearing DTM

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

  3. Changes in PaCO2

    Time frame: At baseline and 30 minutes after wearing DTM

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

  4. Changes in pH

    Time frame: At baseline and 30 minutes after wearing DTM

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

  5. Changes in respiratory rate

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

    Respiratory rate is measured during one minute by visual inspection.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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