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

NCT ID: NCT04794400

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-04

Study Completion Date

2021-03-31

Brief Summary

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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

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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

Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

oxygen mask

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Gustav Torisson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav Torisson, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Locations

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Skåne University Hospital

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2020-07078

Identifier Type: -

Identifier Source: org_study_id

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