Early Spontaneous Breathing in Acute Respiratory Distress Syndrome (BiRDS)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: arterial blood gas measurement each morning; Procedure: APRV

• Study Type: Interventional
• Enrollment (Actual): 702
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Medical Intensive Care Unit, University Hospital of Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Biological: arterial blood gas measurement each morning; Procedure: APRV; Pressure ventilation mode allowing early spontaneous breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause hospital mortality	participants will be followed for the duration of hospital stay, until day 60 maximum.	hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of stay in ICU	day 60
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
Changes in serum levels of proinflammatory cytokines	Hour 1 and Hour 48

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2013
• Primary Completion (Actual): December 16, 2017
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Acute respiratory distress syndrome; Spontaneous breathing; APRV ventilatory mode
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Aspiration; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PHRC 2009-04; 2012-A00551-42 (Other Identifier: IDRCB number (ANSM))