Early LIght Sedation Pressure Support in ARDS Patients

University Hospital, Lille0 sitesDecember 2021

ConditionsARDS, Human

Overview

Phase: N/A
Intervention: Not specified
Conditions: ARDS, Human
Sponsor: University Hospital, Lille
Primary Endpoint: transpulmonary pressure at early stabilization of patient
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

December 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

transpulmonary pressure at early stabilization of patient

Time Frame: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours

transpulmonary pressure (Paw - Peso \< 24 cmH2O)

Secondary Outcomes

oxygenation modification(stabilization of ventilator settings; 1hour after stabilization of ventilator settings)
ventilator free days(during the first 28 days)
arterial pressure modification(stabilization of ventilator settings; 1hour after stabilization of ventilator settings)
muscular volume decrease(at 24 hours; at day of extubation; ICU discharge, an average 16 days)
delirium in ICU(ICU discharge, an average 16 days)
Heart rate modification(stabilization of ventilator settings;1hour after stabilization of ventilator settings)
acquired neuromyopathy(ICU discharge, an average 16 days)
vasopressor dose modification(stabilization of ventilator settings ; 1hour after stabilization of ventilator settings)
change of the functional respiratory parameters from baseline at 6 months(at 6 months)
number of auto extubation(whatever until ICU discharge, an average 16 days)
PTSD(at 6 months)