Acute Lung Injury, ARDS, Extracorporeal Membrane Oxygenation, Lung Diseases, Lung Injury, Acute, Respiratory Distress Syndrome, Respiratory Tract Diseases
Conditions
Keywords
ARDS, ECMO, Ventilation
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.
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.
Interventions
OTHERUltra-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)
OTHERStandard ventilator settings
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison of 2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total time of mechanical ventilation | Start of mechanical ventilation up to 28 days | Total time of mechanical ventilation |
| Evaluation of Cytokines in pg/ml | 2 months | IL-6, IL-8, TNFR1, RAGE, Protein C |
| Evaluation of vitamin D status | Length of ICU stay | 25(OH), 1,25(OH) |
| Evaluation of RAS, ACE, ACE2. | 2 months | Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation. |
| 28 day mortality | Immediately after initiation of ECMO up to 28 days | Mortality from initiation of ECMO till day 28 after initiation of ECMO |
Countries
Austria
Outcome results
None listed