Back to resultsEffect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas
Primary Purpose
Hypoxemic Respiratory Failure, Emergencies, Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mask
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoxemic Respiratory Failure focused on measuring mask, oxygen
Eligibility Criteria
Inclusion Criteria:
Hypoxemia
Exclusion Criteria:
Hypercapnia
Confusion
Sites / Locations
- Epicura
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Nasal canula (flexicare)
Intersurgical aerosol mask with one hole closed by tape
Intersurgical aerosol mask
Arm Description
Patients will receive oxygen by classical nasal cannula
Patients will receive oxygen by classical nasal cannula associated with an aerosol mask partially closed (one lateral hole of the face mask closed by tape)
Patients will receive oxygen by classical nasal cannula associated with an aerosol mask
Outcomes
Primary Outcome Measures
Change in PaO2 and PaCO2
Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ] Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Secondary Outcome Measures
Respiratory frequency
Change in respiratory rate [ Time Frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ] Respiratory frequency is measured during one minute by visual inspection
Full Information
NCT ID
NCT04715854
First Posted
January 3, 2021
Last Updated
February 19, 2021
Sponsor
Laboratory of Movement, Condorcet, Tournai, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT04715854
Brief Title
Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas
Official Title
Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laboratory of Movement, Condorcet, Tournai, Belgium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19.
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 the 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 (1, 2) . However, no study has compared the effect on PaO2, of the addition of a classical aerosol mask above nasal canula.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Respiratory Failure, Emergencies, Covid19
Keywords
mask, oxygen
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
One group will receive oxygen by classical nasal cannula. The second group will receive oxygen by aerosol mask associated with the nasal cannula. Afterward, the sequence will be inverted.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal canula (flexicare)
Arm Type
Active Comparator
Arm Description
Patients will receive oxygen by classical nasal cannula
Arm Title
Intersurgical aerosol mask with one hole closed by tape
Arm Type
Active Comparator
Arm Description
Patients will receive oxygen by classical nasal cannula associated with an aerosol mask partially closed (one lateral hole of the face mask closed by tape)
Arm Title
Intersurgical aerosol mask
Arm Type
Active Comparator
Arm Description
Patients will receive oxygen by classical nasal cannula associated with an aerosol mask
Intervention Type
Device
Intervention Name(s)
Mask
Intervention Description
addition of the mask above the nasal cannulas
Primary Outcome Measure Information:
Title
Change in PaO2 and PaCO2
Description
Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ] Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Respiratory frequency
Description
Change in respiratory rate [ Time Frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ] Respiratory frequency is measured during one minute by visual inspection
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypoxemia
Exclusion Criteria:
Hypercapnia
Confusion
Facility Information:
Facility Name
Epicura
City
Hornu
State/Province
Hainaut
ZIP/Postal Code
7301
Country
Belgium
12. IPD Sharing Statement
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Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas
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