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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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)
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine
Vienna, Austria, Austria
Ventilator free days
Ventilator free days
Time frame: Immediately after initiation of ECMO up to 28 days
Time from randomization to fulfillment of extubation criteria
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: * ARDS resolved * Temperature ≥ 36°C and ≤ 39°C * Low FiO2 (\< 0.5) * PEEP (\< 8 cmH2O) requirement * Able to initiate spontaneous breaths * Tidalvolume \> 5 mL/kg or \> 325 mL * Minute ventilation 5-6 L/min * PaO2/FiO2 \> 200 mmHg * pH ≥ 7.25 * Ability to cough after deflating tube cuff * Respiratory rate 8-30/min * Hemodynamic stability
Time frame: Immediately after initiation of ECMO up to 28 days
Total time of mechanical ventilation
Total time of mechanical ventilation
Time frame: Start of mechanical ventilation up to 28 days
28 day mortality
Mortality from initiation of ECMO till day 28 after initiation of ECMO
Time frame: Immediately after initiation of ECMO up to 28 days
One year mortality
Mortality from initiation of ECMO till one year after initiation of ECMO
Time frame: Immediately after initiation of ECMO up to one year
Incidence of reintubation
Incidence of reintubation
Time frame: Immediately after initiation of ECMO up to 28 days
Length of ICU stay
Length of ICU stay
Time frame: Immediately after initiation of ECMO
Evaluation of RAS, ACE, ACE2.
Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
Time frame: 2 months
Evaluation of Cytokines in pg/ml
IL-6, IL-8, TNFR1, RAGE, Protein C
Time frame: 2 months
Evaluation of vitamin D status
25(OH), 1,25(OH)
Time frame: Length of ICU stay
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