Status:
TERMINATED
Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients
Lead Sponsor:
Sultan Qaboos University
Conditions:
Acute Respiratory Distress Syndrome Caused by COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objective: To determine whether NIV delivered through helmet interface reduces intubation rate among patients with COVID-19 ARDS compared to face-mask NIV and HFNC. Design, setting \& participants: T...
Detailed Description
Inclusion criteria: * \> 18 years of age * confirmed COVID-19 * Within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (ICU) * ARDS according to Berl...
Eligibility Criteria
Inclusion
- \> 18 years of age
- confirmed COVID-19
- Within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (ICU)
- ARDS according to Berlin definition (P/F \< 300) or O2 saturation \< 90% or RR \> 30/min) in room air
- Standard oxygen therapy at flow rate \< 15L/min x 60 minutes
Exclusion
- More than 48 hours of admission to the emergency department, high dependency or intensive care unit
- More than 4 hours on NIV or HFNC before enrolment
- Impending cardiopulmonary arrest
- Need for immediate endotracheal intubation
- Hemodynamic instability or life-threatening arrhythmias
- GCS \< 8
- Active intracranial pathology or high ICP
- Inability to cooperate or protect the airway
- Pregnancy
- Tracheostomy
- DNR or refusing intubation
- Known type 2 respiratory failure
- On chronic home oxygen therapy
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2021
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04715243
Start Date
February 2 2021
End Date
November 11 2021
Last Update
January 12 2022
Active Locations (1)
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1
Sultan Qaboos University Hospital
Muscat, Oman, 123