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Completed

NCT Number: NCT04383821

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

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.

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Key information

Conditions

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, Belgium

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Double-Trunk Mask

Device

The DTM (oxygen delivery system) is worn by the patient for 30 minutes.

Non-Rebreather mask

Device

The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Comfort with the oxygen delivery systems

    Time frame: 30 minutes after wearing both systems

    A Likert scale from -5 to +5 will be used to measure the subjective comfort of the patient while wearing both oxygen delivery systems

  5. Dyspnea with the oxygen delivery systems

    Time frame: 30 minutes after wearing both systems

    A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Feb 8, 2022

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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