Clinical Trial: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Brief Summary:

The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.

The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.


Detailed Summary:
Sponsor: University Hospital, Angers

Current Primary Outcome: all cause hospital mortality [ Time Frame: hospital discharge ]

participants will be followed for the duration of hospital stay, until day 60 maximum.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • all causes mortality [ Time Frame: Day 28 ]
  • number of days alive without mechanical ventilation [ Time Frame: day 28 ]
  • number of days alive without organ failure [ Time Frame: day 28 ]
  • number of patients with refractory hypoxemia [ Time Frame: day 7 ]
  • number of patients requiring adjuvant treatment of hypoxemia [ Time Frame: day 7 ]
  • number of days alive without sedation [ Time Frame: Day 28 ]
  • total amount of sedative drugs [ Time Frame: between baseline and day 7 ]
  • amount of sedative drugs received daily living [ Time Frame: between baseline and day 7 ]
  • number of days alive without vasoactive drugs [ Time Frame: day 28 ]
  • total amount of vasoactive drugs [ Time Frame: between baseline and day 7 ]
  • amount of vasoactive drugs received daily living [ Time Frame: between baseline and day 7 ]
  • Number of patients with a pneumothorax [ Time Frame: day 28 ]
  • Duration of mechanical ventilation [ Time Frame: day 60 ]
  • Duration of stay in ICU [ Time Frame: day 60 ]
  • Changes in serum levels of proinflammatory cytokines [ Time Frame: Hour 1 and Hour 48 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Angers

Dates:
Date Received: May 17, 2013
Date Started: January 2013
Date Completion: January 2018
Last Updated: March 11, 2016
Last Verified: March 2016