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

Primary Purpose

Covid19

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

oxygen mask

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring Critical care, Non-invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Oxygenation

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

Secondary Outcome Measures

Carbon dioxide

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

SpO2

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

Respiratory rate

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

Full Information

NCT ID

NCT04794400

First Posted

March 10, 2021

Last Updated

June 5, 2021

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT04794400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 4, 2021 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Critical care, Non-invasive ventilation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

oxygen mask

Intervention Description

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 Outcome Measure Information:

Title

Oxygenation

Description

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

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Carbon dioxide

Description

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

Time Frame

30 minutes

Title

SpO2

Description

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

Time Frame

60 minutes

Title

Respiratory rate

Description

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustav Torisson, PhD

Organizational Affiliation

Region Skåne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skåne University Hospital

City

Malmö

State/Province

Skåne

ZIP/Postal Code

20502

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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