LIght Sedation Pressure Support

Study Overview
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Brief Summary
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Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular. Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure. The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.

Official Title
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Early LIght Sedation Pressure Support in ARDS Patients

Conditions
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ARDS, Human

Intervention / Treatment
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* Other: decrease of sedation doses and switch of ventilator settings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ARDS (Berlin definition) social insurance Exclusion Criteria: neuromuscular disorders pregnancy need for muscular paralysis need for deep neurosedation more than 24hrs of artificial ventilation cystic fibrosis

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: light sedation pressure support ventilation<br> | Other: decrease of sedation doses and switch of ventilator settings<br>* tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transpulmonary pressure at early stabilization of patient | transpulmonary pressure (Paw - Peso < 24 cmH2O) | when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation modification | PaO2/FiO2 | stabilization of ventilator settings; 1hour after stabilization of ventilator settings | 
| arterial pressure modification | Mean arterial pressure | stabilization of ventilator settings; 1hour after stabilization of ventilator settings | 
| Heart rate modification | heart rate | stabilization of ventilator settings;1hour after stabilization of ventilator settings | 
| vasopressor dose modification | vasopressor dose in norepinephrine equivalent | stabilization of ventilator settings ; 1hour after stabilization of ventilator settings | 
| acquired neuromyopathy | MRC <48/60 | ICU discharge, an average 16 days | 
| muscular volume decrease | quadriceps volume assessed by echography | at 24 hours; at day of extubation; ICU discharge, an average 16 days | 
| ventilator free days | ventilator free days until day 28 | during the first 28 days | 
| delirium in ICU | CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation and Delirium (PAD) guidelines. the presence of delirium is confirmed in the presence of criteria 1, 2 and 3 or 4. | ICU discharge, an average 16 days | 
| change of the functional respiratory parameters from baseline at 6 months | vital capacity, total pulmonary capacity, | at 6 months | 
| PTSD | post traumatic stress disorder impact of event scale > 33 tems are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely) and the total score (ranging from 0 to 88) | at 6 months | 
| number of auto extubation |  | whatever until ICU discharge, an average 16 days |