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NCT04750408 Clinical Trial

NHF vs. COT in Hypoxemic Pandemic Viral Illness

Hypercapnic Respiratory Failure Clinical Trial

— HIVI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04750408
Other study ID # 01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2021
Est. completion date June 22, 2022

Study information
Verified date March 2022
Source Klinikum Emden
Contact Jens Bräunlich, MD
Phone +494921981598
Email highflow@web.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 52
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Klinikum Emden Emden

Sponsors (1)
Lead Sponsor Collaborator
Jens Bräunlich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 paCO2 in mmHg physiological parameter, to assess differences between the two groups 72 hours
Secondary pH physiological parameter, to assess differences between the two groups 72 hours
Secondary escalation of therapy use of noninvasive ventilation, intubation, to assess differences between the two groups 72 hours
Secondary paO2 in mmHg physiological parameter, to assess differences between the two groups 72 hours
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