Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Intervention group Ultra-protective ventilator settings in patients with ARDS and ECMO. |
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)
|
Active Comparator: Control group Standard ventilator settings in patients with ARDS and ECMO. |
Other: Standard ventilator settings
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
|
Outcome Measures
Primary Outcome Measures
- Ventilator free days [Immediately after initiation of ECMO up to 28 days]
Ventilator free days
- Time from randomization to fulfillment of extubation criteria [Immediately after initiation of ECMO up to 28 days]
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
Secondary Outcome Measures
- Total time of mechanical ventilation [Start of mechanical ventilation up to 28 days]
Total time of mechanical ventilation
- 28 day mortality [Immediately after initiation of ECMO up to 28 days]
Mortality from initiation of ECMO till day 28 after initiation of ECMO
- One year mortality [Immediately after initiation of ECMO up to one year]
Mortality from initiation of ECMO till one year after initiation of ECMO
- Incidence of reintubation [Immediately after initiation of ECMO up to 28 days]
Incidence of reintubation
- Length of ICU stay [Immediately after initiation of ECMO]
Length of ICU stay
- Evaluation of RAS, ACE, ACE2. [2 months]
Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
- Evaluation of Cytokines in pg/ml [2 months]
IL-6, IL-8, TNFR1, RAGE, Protein C
Eligibility Criteria
Criteria
Inclusion Criteria:
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Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
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ECMO < 24 hours in situ
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Gender-matched
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Age-matched
Exclusion Criteria:
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BMI > 40
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Expected weaning of ECMO < 3 days (postoperative ECMO)
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Combustion
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Restrictive chest wall impairment
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Pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Roman Ullrich, Ao.Univ.Prof., Department of Anesthesia and Intensive Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MUVienna ARDS-ECMO