Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

Not Applicable

• Conditions: COVID; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; ARDS; Corona Virus Infection
• Interventions: Other: Prone position

• Registration Number: NCT04391140
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-10
• Study Start: 2020-05-13
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-18
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
• Patient treated by nasal high flow.
• Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent).
• Informed consent.
• Beneficiary or affiliated to a social security scheme.

Exclusion Criteria

• Indication of immediate tracheal intubation
• Significant acute progressive circulatory insufficiency
• Impaired alertness, confusion, restlessness
• Body mass index> 40 kg / m2
• Chest trauma or other contraindication to prone position
• Pneumothorax
• Vulnerable person: safeguard of justice
• Pregnant or lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Prone position	Combination of prone position and HFNC

Primary Outcome Measures

Name	Time	Method
Therapeutic failure death or intubation	28 days within randomization	Therapeutic failure: death or intubation

Secondary Outcome Measures

Name	Time	Method
Efficacy of prone position in HFNC patients	28 days within randomization	1. Evolution of the oxygenation (SpO2/FiO2) in prone position.; 2. Efficacy; 1. Length of HFNC therapy; 2. Length of ICU stay; 3. Length of mechanical ventilation (in those who require intubation); 4. ICU and hospital mortality
Feasibility and safety of prone position in HFNC patients	28 days within randomization	1. Comfort measurement using a visual-analog scale.; 2. Presence of complications related with prone position and the use of high-flow nasal cannula: 1. Skin ulcers.; 2. Intravascular lines displacement; 3. HFNC related events (hot air feeling, nasal lesions)

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain