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OpenTrials
Completed

NCT Number: NCT04794400

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital

Malmö, Skåne County, 20502, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxygen mask

Other

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.

Primary outcomes

  1. Oxygenation

    Time frame: 30 minutes

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

Secondary outcomes

  1. Carbon dioxide

    Time frame: 30 minutes

    Change in PaCO2 in KPa from ABG with mask vs without mask

  2. SpO2

    Time frame: 60 minutes

    Change in peripherally measured oxygen saturation before, with and after mask

  3. Respiratory rate

    Time frame: 30 minutes

    Change in respiratory rate (breaths/min) with mask vs without mask

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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