The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.

Study Overview
=================
Brief Summary
-----------------
Patients with severe hypoxemic respiratory failure due to Covid-19 are often treated with oxygen delivered through a high-flow nasal cannula (HFNC). This is according to guidelines. We have made the clinical observation that oxygenation sometimes improves when a mask (e.g. oxygen mask or inhalation mask) is applied on top of the HFNC. This has quickly become a clinical routine at intermediary care units at our hospital, where patients with HFNC are offered to test the intervention (mask + HFNC) as part of clinical routine. This study aims to evaluate this new routine in a standardised way.

Detailed Description
-----------------
Patients with severe covid-19, treated with HFNC, will be approached for consent. If inclusion critera and no exclusion criteria are fulfilled, baseline measurements will be taken without mask, including arterial blood gas analysis (ABG) Then a simple oxygen mask will be applied covering nose and mouth, without providing supplemental oxygen. After 30 minutes with mask + HFNC, new measurements will be taken, including ABG. After 30 minutes, the mask is removed and when steady state occurs, new measurements will be taken, without ABG. Then, the patients could continue using the mask as part of clinical routine

Official Title
-----------------
The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: oxygen mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified Covid19 infection treatment with HFNC Estimated P/F ratio of ≤ 13 KPa Exclusion Criteria: language barrier unable to provide consent risk of deterioration due to study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>An additional oxygen mask was applied for 30 minutes, in patients with ongoing HFNC treatment. | Other: oxygen mask<br>* All patients fulfilling inclusion criteria would be offered to test the intervention as part of their care. The intervention consisted only of a standardised way to evaluate this new clinical routine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | Change in SaO2 in % from ABG with mask vs without mask | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon dioxide | Change in PaCO2 in KPa from ABG with mask vs without mask | 30 minutes | 
| SpO2 | Change in peripherally measured oxygen saturation before, with and after mask | 60 minutes | 
| Respiratory rate | Change in respiratory rate (breaths/min) with mask vs without mask | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive ventilation, Critical care