Clinical trial NCT01862016: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Official title: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome
APRV ventilatory mode
Spontaneous breathing
Intensive Care Unit
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-05-24
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Within 1 week of a known clinical insult or new or worsening respiratory symptoms
* Intubation and mechanical ventilation
* Bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules lung
* Report PaO2 / FiO2 ≤ 200 mmHg with a PEP of at least 5 cmH2O
* Respiratory failure not fully explained by cardiac failure or fluid overload
* Criteria 1, 2 and 3 presents jointly for less than 48 hours
* Consent to participate obtained either from the patient himself or from a relative.

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Predictable duration of the mechanical ventilation on endotracheal tube lower than 48 hours
* Patient being in period of exclusion further to the participation in another biomedical study
* intracranial hypertension (suspected or confirmed)
* known or suspected COPD
* Chronic respiratory failure treated by long-term oxygen and / or long-term respiratory support
* Morbid obesity defined as weight greater than 1 kg / cm
* Sickle Cell Disease
* Marrow recent transplant, post-chemotherapy aplasia
* Widened burns (\> 30% body surface area)
* Severe hepatic cirrhosis (Child-Pugh C)
* Pneumothorax (drained or not)
* Treatment with extracorporeal support (ECMO)
* Decision of active therapeutic limitation
* Unavailability of the model of respirator that must be used in the study
* Failure to obtain a consent by persons authorized to do so.
* Patient under law protection.
* Person non-beneficiary of a social security system

Primary outcomes:
measure: all cause hospital mortality
timeFrame: hospital discharge
Secondary outcomes:
measure: all causes mortality
timeFrame: Day 28
measure: number of days alive without mechanical ventilation
timeFrame: day 28
measure: number of days alive without organ failure
timeFrame: day 28
measure: number of patients with refractory hypoxemia
timeFrame: day 7
measure: number of patients requiring adjuvant treatment of hypoxemia
timeFrame: day 7
measure: number of days alive without sedation
timeFrame: Day 28
measure: total amount of sedative drugs
timeFrame: between baseline and day 7
measure: amount of sedative drugs received daily living
timeFrame: between baseline and day 7
measure: number of days alive without vasoactive drugs
timeFrame: day 28
measure: total amount of vasoactive drugs
timeFrame: between baseline and day 7
measure: amount of vasoactive drugs received daily living
timeFrame: between baseline and day 7
measure: Number of patients with a pneumothorax
timeFrame: day 28
measure: Duration of mechanical ventilation
timeFrame: day 60
measure: Duration of stay in ICU
timeFrame: day 60
measure: Changes in serum levels of proinflammatory cytokines
timeFrame: Hour 1 and Hour 48
Other outcomes:
Locations:
city: Angers
country: France
facility: Medical Intensive Care Unit, University Hospital of Angers
Study officials:
References: