BiRDS: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Sponsor

University Hospital, Angers (Other)

Overall Status

Unknown status

CT.gov ID

NCT01862016

Collaborator

(none)

702

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Procedure: APRV Biological: arterial blood gas measurement each morning	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

702 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Actual Study Start Date :

Feb 28, 2013

Actual Primary Completion Date :

Dec 16, 2017

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VAC mode, Controlled ventilation From randomization, patients are put under controlled ventilation with specific settings	Biological: arterial blood gas measurement each morning
Experimental: APRV mode, Spontaneous breathing During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings	Procedure: APRV Pressure ventilation mode allowing early spontaneous breathing Biological: arterial blood gas measurement each morning

Arm

Intervention/Treatment

Active Comparator: VAC mode, Controlled ventilation

From randomization, patients are put under controlled ventilation with specific settings

Biological: arterial blood gas measurement each morning

Experimental: APRV mode, Spontaneous breathing

During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings

Procedure: APRV

Pressure ventilation mode allowing early spontaneous breathing

Biological: arterial blood gas measurement each morning

Outcome Measures

Primary Outcome Measures

all cause hospital mortality [hospital discharge]
participants will be followed for the duration of hospital stay, until day 60 maximum.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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