Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: APRV
* Biological: arterial blood gas measurement each morning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VAC mode, Controlled ventilation<br>From randomization, patients are put under controlled ventilation with specific settings | Biological: arterial blood gas measurement each morning<br> <br> |
| Experimental: APRV mode, Spontaneous breathing<br>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<br>* Pressure ventilation mode allowing early spontaneous breathing<br>Biological: arterial blood gas measurement each morning<br> <br> |

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory distress syndrome, APRV ventilatory mode, Spontaneous breathing, Intensive Care Unit