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

Primary Purpose

COVID, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Standard interface
Double-Trunk Mask
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

O2 DTM+

O2 DTM-

Arm Description

The standard nasal cannula interface is accompanied with the DTM

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Changes in PaO2
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Changes in PaCO2
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.
Changes in pH
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Changes in respiratory rate
Respiratory rate is measured during one minute by visual inspection.

Full Information

First Posted
April 8, 2020
Last Updated
June 5, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04346420
Brief Title
Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
Official Title
Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Hypoxemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O2 DTM+
Arm Type
Experimental
Arm Description
The standard nasal cannula interface is accompanied with the DTM
Arm Title
O2 DTM-
Arm Type
Active Comparator
Arm Description
The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM
Intervention Type
Other
Intervention Name(s)
Standard interface
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
Double-Trunk Mask
Intervention Description
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 Outcome Measure Information:
Title
Change in O2 output
Description
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 Outcome Measure Information:
Title
Comfort with the interfaces
Description
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
Title
Changes in PaO2
Description
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
Title
Changes in PaCO2
Description
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
Title
Changes in pH
Description
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
Title
Changes in respiratory rate
Description
Respiratory rate is measured during one minute by visual inspection.
Time Frame
At baseline and 30 minutes after wearing both systems

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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

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