Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas

February 19, 2021 updated by: frédéric Duprez, Laboratory of Movement, Condorcet, Tournai, Belgium

Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Hainaut
      • Hornu, Hainaut, Belgium, 7301
        • EpiCURA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hypoxemia

Exclusion Criteria:

Hypercapnia

Confusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nasal canula (flexicare)
Patients will receive oxygen by classical nasal cannula
Device: Mask
addition of the mask above the nasal cannulas
Active Comparator: Intersurgical aerosol mask with one hole closed by tape
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)
Device: Mask
addition of the mask above the nasal cannulas
Active Comparator: Intersurgical aerosol mask
Patients will receive oxygen by classical nasal cannula associated with an aerosol mask
Device: Mask
addition of the mask above the nasal cannulas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PaO2 and PaCO2
Time Frame: 30 minutes
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
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory frequency
Time Frame: 1 minute
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
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratory of Movement, Condorcet, Tournai, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 3, 2021

First Submitted That Met QC Criteria

January 16, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lmcondorcet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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