NCT03764319

Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.

Detailed description

The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO. The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.

Conditions

• ARDS
• Acute Lung Injury
• Extracorporeal Membrane Oxygenation
• Respiratory Distress Syndrome
• Respiratory Tract Diseases
• Lung Diseases
• Lung Injury, Acute

Interventions

Type	Name	Description
OTHER	Ultra-protective ventilator settings	4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 \< Plateau pressure \< 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume \> 4 mL/kg Predicted body weight (PBW)); \< 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)
OTHER	Standard ventilator settings	12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Timeline

• Start date: 2018-11-06
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2018-12-05
• Last updated: 2025-04-17

Locations

1 site across 1 country: Austria