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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: oxygen mask

• Registration Number: NCT04794400
• Lead Sponsor: Region Skane

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

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-05
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	oxygen mask	An additional oxygen mask was applied for 30 minutes, in patients with ongoing HFNC treatment.

Primary Outcome Measures

Name	Time	Method
Oxygenation	30 minutes	Change in SaO2 in % from ABG with mask vs without mask

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Skåne, Sweden