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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Ultra-protective ventilator settings in patients with ARDS and ECMO. |
|
| Control group | Active Comparator | Standard ventilator settings in patients with ARDS and ECMO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-protective ventilator settings | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days | Ventilator free days | 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:
| Immediately after initiation of ECMO up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total time of mechanical ventilation | Total time of mechanical ventilation | Start of mechanical ventilation up to 28 days |
| 28 day mortality | Mortality from initiation of ECMO till day 28 after initiation of ECMO |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Ullrich, Ao.Univ.Prof. | Department of Anesthesia and Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine | Vienna | Austria | 1090 | Austria |
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Comparison of 2 groups
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|
| Standard ventilator settings | Other | 12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure |
|
| Immediately after initiation of ECMO up to 28 days |
| One year mortality | Mortality from initiation of ECMO till one year after initiation of ECMO | Immediately after initiation of ECMO up to one year |
| Incidence of reintubation | Incidence of reintubation | Immediately after initiation of ECMO up to 28 days |
| Length of ICU stay | Length of ICU stay | Immediately after initiation of ECMO |
| Evaluation of RAS, ACE, ACE2. | Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation. | 2 months |
| Evaluation of Cytokines in pg/ml | IL-6, IL-8, TNFR1, RAGE, Protein C | 2 months |
| Evaluation of vitamin D status | 25(OH), 1,25(OH) | Length of ICU stay |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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