NCT04750408

Brief Summary

The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

January 21, 2021

Last Update Submit

March 29, 2022

Conditions

Acute Viral BronchitisHypoxemic Respiratory FailureHypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Rox index

    (SpO2/FiO2)/RR = index without a unit, mean Rox-index in the two groups, comparison between the groups (significant differences), physiological parameter, to assess differences between the two groups

    72 hours

Secondary Outcomes (4)

  • paCO2 in mmHg

    72 hours

  • pH

    72 hours

  • escalation of therapy

    72 hours

  • paO2 in mmHg

    72 hours

Study Arms (2)

Oxygen use

ACTIVE COMPARATOR

Patients will use standard oxygen via face mask of nasal prongs as usual care.

Device: Standard oxygen

NHF use

EXPERIMENTAL

Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow.

Device: Nasal high-flow

Interventions

Standard oxygenDEVICE

COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).

Also known as: COT
Oxygen use
Nasal high-flowDEVICE

F is combination of room air supplemented with oxygen can be better patients. This gas mixture will be provided to the patient with a specialized nasal prong.

Also known as: NHF
NHF use

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute hyperemic viral illness
  • acute hyperemic or hypercapnia respiratory failure

You may not qualify if:

  • intubation criteria
  • indication for NIV therapy
  • influences of primary endpoint (rip fracture, lung embolism)
  • tracheostomy
  • other interventional trials
  • noncompliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Emden

Emden, 26721, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jens Bräunlich, MD

    chair

    STUDY CHAIR

Central Study Contacts

Jens Bräunlich, MD

CONTACT

+494921981598highflow@web.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair Pneumology and Respiratory Medicine

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 11, 2021

Study Start

January 22, 2021

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

original/ raw data

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
after the end of the study
Access Criteria
on request

Locations

DE(1)