NCT01862016

Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
PROCEDURE	APRV	Pressure ventilation mode allowing early spontaneous breathing
BIOLOGICAL	arterial blood gas measurement each morning

Timeline

• Start date: 2013-02-28
• Primary completion: 2017-12-16
• Completion: 2019-05-01
• First posted: 2013-05-24
• Last updated: 2019-03-19

Locations

1 site across 1 country: France