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NCT04794400 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04794400
Other study ID # 2020-07078
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2021
Est. completion date March 31, 2021

Study information
Verified date June 2021
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• oxygen mask
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.

Locations
Country Name City State
Sweden Skåne University Hospital Malmö Skåne

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygenation Change in SaO2 in % from ABG with mask vs without mask 30 minutes
Secondary Carbon dioxide Change in PaCO2 in KPa from ABG with mask vs without mask 30 minutes
Secondary SpO2 Change in peripherally measured oxygen saturation before, with and after mask 60 minutes
Secondary Respiratory rate Change in respiratory rate (breaths/min) with mask vs without mask 30 minutes
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