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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04794400

Enrollment

Registered

2021-03-12

Start date

2021-02-04

Completion date

2021-03-31

Last updated

2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Critical care, Non-invasive ventilation

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

Interventions

OTHERoxygen 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Oxygenation	30 minutes	Change in SaO2 in % from ABG with mask vs without mask

Secondary

Measure	Time frame	Description
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026