NCT04794400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

March 10, 2021

Last Update Submit

June 5, 2021

Conditions

Covid19

Keywords

Critical careNon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Oxygenation

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

    30 minutes

Secondary Outcomes (3)

  • Carbon dioxide

    30 minutes

  • SpO2

    60 minutes

  • Respiratory rate

    30 minutes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: oxygen mask

Interventions

oxygen maskOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Verified Covid19 infection
  • treatment with HFNC
  • Estimated P/F ratio of ≤ 13 KPa

You may not qualify if:

  • language barrier
  • unable to provide consent
  • risk of deterioration due to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Skåne County, 20502, Sweden

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gustav Torisson, PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

February 4, 2021

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)