Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Ventilator free days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention group
Ultra-protective ventilator settings in patients with ARDS and ECMO.
Intervention: Ultra-protective ventilator settings (Other)
Control group
Standard ventilator settings in patients with ARDS and ECMO.
Intervention: Standard ventilator settings (Other)
Outcomes
Primary Outcomes
Ventilator free days
Time Frame: Immediately after initiation of ECMO up to 28 days
Ventilator free days
Time from randomization to fulfillment of extubation criteria
Time Frame: 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 Outcomes
- Total time of mechanical ventilation(Start of mechanical ventilation up to 28 days)
- 28 day mortality(Immediately after initiation of ECMO up to 28 days)
- One year mortality(Immediately after initiation of ECMO up to one year)
- Incidence of reintubation(Immediately after initiation of ECMO up to 28 days)
- Length of ICU stay(Immediately after initiation of ECMO)
- Evaluation of RAS, ACE, ACE2.(2 months)
- Evaluation of Cytokines in pg/ml(2 months)
- Evaluation of vitamin D status(Length of ICU stay)
Investigators
Martina Hermann
Investigator
Medical University of Vienna