NL-OMON53874
Not Yet Recruiting
N/A
Early PReserved SPONtaneous breathing activity in mechanically ventilated patients with acute respiratory distress syndrome - The PReSPON Randomized Controlled Trial - PReSPO
niversity Hospital Bonn0 sites10 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ARDS
- Sponsor
- niversity Hospital Bonn
- Enrollment
- 10
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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