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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxemic Respiratory Failure, Emergencies, Covid19

Intervention / Treatment
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* Device: Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypoxemia Exclusion Criteria: Hypercapnia Confusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mask, oxygen