Back to resultsNHF vs. COT in Hypoxemic Pandemic Viral Illness (HIVI)
Primary Purpose
Acute Viral Bronchitis, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Standard oxygen
Nasal high-flow
Sponsored by
About this trial
This is an interventional treatment trial for Acute Viral Bronchitis
Eligibility Criteria
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
Sites / Locations
- Klinikum EmdenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oxygen use
NHF use
Arm Description
Patients will use standard oxygen via face mask of nasal prongs as usual care.
Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
paCO2 in mmHg
physiological parameter, to assess differences between the two groups
pH
physiological parameter, to assess differences between the two groups
escalation of therapy
use of noninvasive ventilation, intubation, to assess differences between the two groups
paO2 in mmHg
physiological parameter, to assess differences between the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04750408
Brief Title
NHF vs. COT in Hypoxemic Pandemic Viral Illness
Acronym
HIVI
Official Title
Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Anticipated)
Study Completion Date
June 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Bräunlich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchitis, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxygen use
Arm Type
Active Comparator
Arm Description
Patients will use standard oxygen via face mask of nasal prongs as usual care.
Arm Title
NHF use
Arm Type
Experimental
Arm Description
Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow.
Intervention Type
Device
Intervention Name(s)
Standard oxygen
Other Intervention Name(s)
COT
Intervention Description
COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).
Intervention Type
Device
Intervention Name(s)
Nasal high-flow
Other Intervention Name(s)
NHF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rox index
Description
(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 Outcome Measure Information:
Title
paCO2 in mmHg
Description
physiological parameter, to assess differences between the two groups
Time Frame
72 hours
Title
pH
Description
physiological parameter, to assess differences between the two groups
Time Frame
72 hours
Title
escalation of therapy
Description
use of noninvasive ventilation, intubation, to assess differences between the two groups
Time Frame
72 hours
Title
paO2 in mmHg
Description
physiological parameter, to assess differences between the two groups
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Bräunlich, MD
Phone
+494921981598
Email
highflow@web.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Bräunlich, MD
Organizational Affiliation
chair
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Emden
City
Emden
ZIP/Postal Code
26721
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Bräunlich, MD
Phone
+494921981598
Email
highflow@web.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
original/ raw data
IPD Sharing Time Frame
after the end of the study
IPD Sharing Access Criteria
on request
Learn more about this trial
NHF vs. COT in Hypoxemic Pandemic Viral Illness
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