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Clinical Trials/NCT04794400
NCT04794400CompletedNot Applicable

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

Region Skane2 sites in 1 country18 target enrollmentStarted: February 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Oxygenation

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Oxygenation

Time Frame: 30 minutes

Change in SaO2 in % from ABG with mask vs without mask

Secondary Outcomes

  • Carbon dioxide(30 minutes)
  • SpO2(60 minutes)
  • Respiratory rate(30 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gustav Torisson

Principal Investigator

Region Skane

Study Sites (2)

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