Early PReserved SPONtaneous breathing activity in mechanically ventilated patients with acute respiratory distress syndrome - The PReSPON Randomized Controlled Trial - PReSPO

niversity Hospital Bonn0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•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
•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.

发起方

niversity Hospital Bonn