NCT04349618

Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia

Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O). Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.

Conditions

• Acute Respiratory Distress Syndrome
• COVID19
• Sars-CoV2
• Pneumonia

Interventions

Type	Name	Description
OTHER	PROTECTIVE VENTILATION	Protective ventilation with tidal volume 6 mL/kg of predicted body weight further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
OTHER	ULTRAPROTECTIVE VENTILATION	Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial

Timeline

• Start date: 2020-04-15
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2020-04-16
• Last updated: 2025-12-10

Locations

11 sites across 1 country: France