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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Hypoxemia

Intervention / Treatment
-----------------
* Other: Standard Oxygen Delivery System
* Other: Double-Trunk Mask
* Other: Surgical Mask


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-flow nasal cannula<br>The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM | Other: Standard Oxygen Delivery System<br>* The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.<br>|
| Experimental: Double-Trunk Mask<br>The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). | Other: Double-Trunk Mask<br>* 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.<br>|
| Experimental: Surgical Mask<br>The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). | Other: Surgical Mask<br>* The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PaO2 | Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system | At baseline and 30 minutes after wearing the randomized oxygen delivery system | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PaCO2 | Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system. | At baseline and 30 minutes after wearing the randomized oxygen delivery system | 
| Change in pH | Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system. | At baseline and 30 minutes after wearing the randomized oxygen delivery system | 
| Change in respiratory rate | Respiratory rate is measured during one minute by visual inspection. | At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system | 
| Change in dyspnea | Dyspnea is rated with a visual analogic scale (0 to 100mm). | At baseline and 60 minutes after wearing the randomized oxygen delivery system | 
| 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. | At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double-Trunk Mask, Surgical Mask