NHF vs. COT in Hypoxemic Pandemic Viral Illness (HIVI)

March 29, 2022 updated by: Jens Bräunlich

Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jens Bräunlich, MD
  • Phone Number: +494921981598
  • Email: highflow@web.de

Study Locations

  • Germany
      • Emden, Germany, 26721
        • Recruiting
        • Klinikum Emden
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen use
Patients will use standard oxygen via face mask of nasal prongs as usual care.
Device: Standard oxygen
COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).
Other Names:
  • COT
Experimental: NHF use
Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow.
Device: Nasal high-flow
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.
Other Names:
  • NHF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rox index
Time Frame: 72 hours
(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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
paCO2 in mmHg
Time Frame: 72 hours
physiological parameter, to assess differences between the two groups
72 hours
pH
Time Frame: 72 hours
physiological parameter, to assess differences between the two groups
72 hours
escalation of therapy
Time Frame: 72 hours
use of noninvasive ventilation, intubation, to assess differences between the two groups
72 hours
paO2 in mmHg
Time Frame: 72 hours
physiological parameter, to assess differences between the two groups
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Bräunlich

Investigators

  • Study Chair: Jens Bräunlich, MD, Chair

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Anticipated)

June 22, 2022

Study Completion (Anticipated)

June 22, 2022

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

original/ raw data

IPD Sharing Time Frame

after the end of the study

IPD Sharing Access Criteria

on request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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