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Clinical Trials/NL-OMON53874
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
ConditionsARDS10024967

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversity Hospital Bonn

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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