Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) — COVEN  

Mechanical Ventilation Clinical Trial

Official title: Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study

Status Recruiting

Clinical Trial Summary

This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.

Clinical Trial Description

Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following prespecified PEEP and FiO2 combinations chosen dynamically targeting oxygenation. Tidal volume is set at 4-6 mL/Kg of predicted body weight (PBW) and plateau pressure is kept below 30 centimeters of water (cmH2O). Respiratory rate can be as high as 35 breaths per minute titrated to a potential of hydrogen (pH) 7.30-7.45. As oxygenation improves, patients are transitioned to assisted ventilation and then to pressure support ventilation until they are ready to be liberated from the ventilator. During this phase, no attempt is made to control plateau pressures or tidal volumes. In the intervention arm, minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period will be targeted. The controlled phase will last at least 48 hours. PEEP will be selected according to a PEEP titration maneuver with EIT at the start of the intervention. This PEEP level will be kept until extubation. Respiratory rate can be as high as 50 breaths per minute targeting a pH of 7.15-7.45. ;

Related Conditions & MeSH terms

• COVID-19
• Mechanical Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome
• Syndrome

• NCT number: NCT04497454
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Contact: Eduardo LV Costa, PhD
• Phone: +551130617361
• Email: eduardoleitecosta@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2020
• Completion date: December 1, 2022