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Status unknownNCT04750408HIVIUpdated Mar 31, 2022

NHF vs. COT in Hypoxemic Pandemic Viral Illness

An interventional study of Standard oxygen and Nasal high-flow in Acute Viral Bronchitis, Hypoxemic Respiratory Failure and Hypercapnic Respiratory Failure, sponsored by Jens Bräunlich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Jens Bräunlich · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Viral Bronchitis
  • Hypoxemic Respiratory Failure
  • Hypercapnic Respiratory Failure
03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's planned enrollment of 52 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Jens Bräunlich is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • intubation criteria
  • indication for NIV therapy
  • influences of primary endpoint (rip fracture, lung embolism)
  • tracheostomy
  • other interventional trials
  • noncompliance
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Oxygen use

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

    Device: Standard oxygen

  • Experimental
    NHF use

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

    Device: Nasal high-flow

Interventions

  • DeviceStandard oxygen

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

    Also known as: COT

  • DeviceNasal 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.

    Also known as: NHF

06

What researchers measure

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

    Time frame: 72 hours

Secondary outcomes

  1. paCO2 in mmHg

    physiological parameter, to assess differences between the two groups

    Time frame: 72 hours

  2. pH

    physiological parameter, to assess differences between the two groups

    Time frame: 72 hours

  3. escalation of therapy

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

    Time frame: 72 hours

  4. paO2 in mmHg

    physiological parameter, to assess differences between the two groups

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
  • Klinikum Emden
    Emden, 26721, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — original/ raw data

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04750408
Lead sponsor
Jens Bräunlich
Responsible party
Jens Bräunlich (Chair Pneumology and Respiratory Medicine, Klinikum Emden) — Sponsor-investigator
First posted
Feb 11, 2021
Start date
Jan 22, 2021
Primary completion
Jun 22, 2022 (estimated)
Completion
Jun 22, 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Jens Bräunlich, MD
Contact
highflow@web.de
+494921981598
Jens Bräunlich, MD
study chair · chair

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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