ARDS, Human
Conditions
Brief summary
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.
Interventions
OTHERdecrease of sedation doses and switch of ventilator settings
tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transpulmonary pressure at early stabilization of patient | when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours | transpulmonary pressure (Paw - Peso \< 24 cmH2O) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| arterial pressure modification | stabilization of ventilator settings; 1hour after stabilization of ventilator settings | Mean arterial pressure |
| Heart rate modification | stabilization of ventilator settings;1hour after stabilization of ventilator settings | heart rate |
| vasopressor dose modification | stabilization of ventilator settings ; 1hour after stabilization of ventilator settings | vasopressor dose in norepinephrine equivalent |
| acquired neuromyopathy | ICU discharge, an average 16 days | MRC \<48/60 |
| muscular volume decrease | at 24 hours; at day of extubation; ICU discharge, an average 16 days | quadriceps volume assessed by echography |
| oxygenation modification | stabilization of ventilator settings; 1hour after stabilization of ventilator settings | PaO2/FiO2 |
| delirium in ICU | ICU discharge, an average 16 days | 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. |
| change of the functional respiratory parameters from baseline at 6 months | at 6 months | vital capacity, total pulmonary capacity, |
| PTSD | at 6 months | 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) |
| number of auto extubation | whatever until ICU discharge, an average 16 days | — |
| ventilator free days | during the first 28 days | ventilator free days until day 28 |
Outcome results
None listed