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

Medical University of Vienna

Status: Completed

Conditions: Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Acute Lung Injury; Lung Injury, Acute; ARDS; Extracorporeal Membrane Oxygenation

Treatments: Other: Standard ventilator settings; Other: Ultra-protective ventilator settings

Study type: Interventional

Funder types: Other

Identifiers

NCT03764319

MUVienna ARDS-ECMO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
• ECMO < 24 hours in situ
• Gender-matched
• Age-matched

Exclusion criteria

• BMI > 40
• Expected weaning of ECMO < 3 days (postoperative ECMO)
• Combustion
• Restrictive chest wall impairment
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

Ultra-protective ventilator settings in patients with ARDS and ECMO.

Treatment:

Other: Ultra-protective ventilator settings

Control group

Active Comparator group

Description:

Standard ventilator settings in patients with ARDS and ECMO.

Treatment:

Other: Standard ventilator settings