Early PReserved SPONtaneous breathing activity in mechanically ventilated patients with acute respiratory distress syndrome - The PReSPON Randomized Controlled Trial
- Conditions
- ARDS10024967
- Registration Number
- NL-OMON53874
- Lead Sponsor
- niversity Hospital Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
1. Moderate to severe ARDS for <= 48 hours according to the Berlin definition is
defined by acute onset of:
a. PaO2/FiO2 <= 200 mmHg (equivalent to <= 26.7 kPa) under invasive mechanical
ventilation with PEEP >= 5 cmH2O
b. Bilateral infiltrates documented by chest radiograph
c. Not fully explained by cardiac failure or fluid overload (e.g.
echocardiography)
2. Requirement for positive pressure ventilation via an endotracheal tube/
tracheotomy
3. Informed consent according to local regulations
4. Age >= 18 years
5. Expected duration of invasive mechanical ventilation > 48 hours at
randomization
1. Need of extracorporeal lung support, high frequency oscillation and/or
inhaled vasodilators for severe hypoxemia at randomization
2. Woman known to be pregnant, lactating or having a positive or indeterminate
pregnancy test
3. Neuromuscular disease that impairs ability to ventilate spontaneously
4. Severe chronic respiratory disease (e.g. COPD, pulmonary fibrosis, and other
chronic diseases of the lung, chest wall or neuromuscular system) requiring
home oxygen therapy or mechanical ventilation (non-invasive ventilation or via
tracheotomy) except for Continuous Positive Airway Pressure (CPAP) or
non-invasive Biphasic Positive Airway Pressure (BiPAP) used solely for
sleep-disordered breathing
5. Chronic kidney disease stage V (requirement of dialysis) according to the
K/DOQI definition of chronic kidney disease
6. Massive diffuse alveolar haemorrhage
7. Recent lung transplant < 12 months
8. Morbid obesity defined as weight greater than 1 kg / cm
9. Burns > 70% total body surface
10. Suspected or known elevated intracranial pressure
11. Chronic liver disease (Child-Pugh grade C)
12. Ongoing chemotherapy and/or bone marrow transplantation within the last 3
months
13. Moribund patient not expected to survive 48 hours
14. Patients not expected to survive 90 days on the basis of the premorbid
15. Patient, surrogate, or physician not committed to full life support.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy endpoints:<br /><br>• All-cause mortality at study day 28 (D28)<br /><br>• Number of ventilator free days (VFD) until D28</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoint(s):<br /><br>• All-cause mortality at study day 90 (D90)<br /><br>• Number of vasoactive drug free days until D28<br /><br>• Number of renal support free days until D28<br /><br>• Number of ICU free days until D28<br /><br>• Sequential Organ Failure Assessment (SOFA) score during ICU stay</p><br>