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

Hospital Universitari Vall d'Hebron Research Institute248 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

248

Conditions

COVID ARDS Acute Respiratory Distress Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Therapeutic failure death or intubation

Therapeutic failure: death or intubation

Time frame: 28 days within randomization

Secondary Outcomes

Feasibility and safety of prone position in HFNC patients

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)

Time frame: 28 days within randomization

Efficacy of prone position in HFNC patients

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

Time frame: 28 days within randomization

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes