NHF vs. COT in Hypoxemic Pandemic Viral Illness

Not Applicable

• Conditions: Acute Viral Bronchitis; Hypoxemic Respiratory Failure; Hypercapnic Respiratory Failure
• Interventions: Device: Nasal high-flow; Device: Standard oxygen

• Registration Number: NCT04750408
• Lead Sponsor: Jens Bräunlich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study Start: 2021-01-22
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NHF use	Nasal high-flow	Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow.
Oxygen use	Standard oxygen	Patients will use standard oxygen via face mask of nasal prongs as usual care.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
paCO2 in mmHg	72 hours	physiological parameter, to assess differences between the two groups
pH	72 hours	physiological parameter, to assess differences between the two groups
escalation of therapy	72 hours	use of noninvasive ventilation, intubation, to assess differences between the two groups
paO2 in mmHg	72 hours	physiological parameter, to assess differences between the two groups

Trial Locations

Locations (1)

Klinikum Emden; 🇩🇪 Emden, Germany