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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346420
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Condition or disease Intervention/treatment Phase
COVID Hypoxemia Other: Standard interface Device: Double-Trunk Mask Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: O2 DTM+
The standard nasal cannula interface is accompanied with the DTM
Device: Double-Trunk Mask
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%.

Active Comparator: O2 DTM-
The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM
Other: Standard interface
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%.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346420


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04346420    
Other Study ID Numbers: DTM-001
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory