Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Not Applicable

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: APRV; Biological: arterial blood gas measurement each morning

• Registration Number: NCT01862016
• Lead Sponsor: University Hospital, Angers

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 Description

Not available

Study Timeline

• Study Start: 2013-02-28
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Primary Completion: 2017-12-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 702

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APRV mode, Spontaneous breathing	APRV	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
APRV mode, Spontaneous breathing	arterial blood gas measurement each morning	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
VAC mode, Controlled ventilation	arterial blood gas measurement each morning	From randomization, patients are put under controlled ventilation with specific settings

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Intensive Care Unit, University Hospital of Angers; 🇫🇷 Angers, France