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HIVI: NHF vs. COT in Hypoxemic Pandemic Viral Illness

Sponsor
Jens Bräunlich (Other)
Overall Status
Recruiting
CT.gov ID
NCT04750408
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Standard oxygen
  • Device: Nasal high-flow
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness
Actual Study Start Date :
Jan 22, 2021
Anticipated Primary Completion Date :
Jun 22, 2022
Anticipated Study Completion Date :
Jun 22, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rox index [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

    Secondary Outcome Measures

    1. paCO2 in mmHg [72 hours]

      physiological parameter, to assess differences between the two groups

    2. pH [72 hours]

      physiological parameter, to assess differences between the two groups

    3. escalation of therapy [72 hours]

      use of noninvasive ventilation, intubation, to assess differences between the two groups

    4. paO2 in mmHg [72 hours]

      physiological parameter, to assess differences between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum Emden Emden Germany 26721

    Sponsors and Collaborators

    • Jens Bräunlich

    Investigators

    • Study Chair: Jens Bräunlich, MD, chair

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jens Bräunlich, Chair Pneumology and Respiratory Medicine, Klinikum Emden
    ClinicalTrials.gov Identifier:
    NCT04750408
    Other Study ID Numbers:
    • 01
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bronchitis
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Mar 31, 2022