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Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19

Primary Purpose

Covid19, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Standard Oxygen Delivery System
Double-Trunk Mask
Surgical 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 Covid19 focused on measuring Double-Trunk Mask, Surgical Mask

Eligibility Criteria

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

Inclusion Criteria:

  • COVID-19 positive
  • SpO2 between 92 and 96% with low-flow oxygen therapy
  • Oxygen output at baseline between 3 and 7 L/min.

Exclusion Criteria:

  • Pulmonary disease with hypercapnia
  • Confusion
  • 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 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Low-flow nasal cannula

Double-Trunk Mask

Surgical Mask

Arm Description

The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM

The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in PaCO2
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.
Change in pH
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Change in respiratory rate
Respiratory rate is measured during one minute by visual inspection.
Change in dyspnea
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Change in O2 output
The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.

Full Information

First Posted
November 13, 2020
Last Updated
March 8, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04629989
Brief Title
Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19
Official Title
The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (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 compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).
Detailed Description
Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hypoxemia
Keywords
Double-Trunk Mask, Surgical Mask

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-flow nasal cannula
Arm Type
Active Comparator
Arm Description
The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM
Arm Title
Double-Trunk Mask
Arm Type
Experimental
Arm Description
The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).
Arm Title
Surgical Mask
Arm Type
Experimental
Arm Description
The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).
Intervention Type
Other
Intervention Name(s)
Standard Oxygen Delivery System
Intervention Description
The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Intervention Type
Other
Intervention Name(s)
Double-Trunk Mask
Intervention Description
The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Intervention Type
Other
Intervention Name(s)
Surgical Mask
Intervention Description
The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Primary Outcome Measure Information:
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 the randomized oxygen delivery system
Secondary Outcome Measure Information:
Title
Change 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 the randomized oxygen delivery system
Title
Change 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 the randomized oxygen delivery system
Title
Change in respiratory rate
Description
Respiratory rate is measured during one minute by visual inspection.
Time Frame
At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Title
Change in dyspnea
Description
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Time Frame
At baseline and 60 minutes after wearing the randomized oxygen delivery system
Title
Change in O2 output
Description
The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.
Time Frame
At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19 positive SpO2 between 92 and 96% with low-flow oxygen therapy Oxygen output at baseline between 3 and 7 L/min. Exclusion Criteria: Pulmonary disease with hypercapnia Confusion Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19

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