Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS
NCT04391140 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2020-08-18
Summary
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
Conditions
- COVID
- ARDS
- Acute Respiratory Distress Syndrome
- Acute Respiratory Failure
- Corona Virus Infection
Interventions
- OTHER
-
Prone position
HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
Sponsors & Collaborators
-
Hospital Universitari Vall d'Hebron Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-13
- Primary Completion
- 2020-12-31
- Completion
- 2021-06-30
Countries
- Spain
Study Locations
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