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

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Corona Virus Infection; COVID; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; ARDS

Treatments: Other: Prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT04391140

PR(AG)198/2020

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Experimental

Experimental group

Description:

Combination of prone position and HFNC

Treatment:

Other: Prone position

Control

No Intervention group

Description:

Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.