LIght Sedation Pressure Support

Not Applicable

Withdrawn

• Conditions: ARDS, Human
• Interventions: Other: decrease of sedation doses and switch of ventilator settings

• Registration Number: NCT03783468
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-21
• Study Start: 2021-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
light sedation pressure support ventilation	decrease of sedation doses and switch of ventilator settings	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
oxygenation modification	stabilization of ventilator settings; 1hour after stabilization of ventilator settings	PaO2/FiO2
ventilator free days	during the first 28 days	ventilator free days until day 28
arterial pressure modification	stabilization of ventilator settings; 1hour after stabilization of ventilator settings	Mean arterial pressure
muscular volume decrease	at 24 hours; at day of extubation; ICU discharge, an average 16 days	quadriceps volume assessed by echography
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.
Heart rate modification	stabilization of ventilator settings;1hour after stabilization of ventilator settings	heart rate
acquired neuromyopathy	ICU discharge, an average 16 days	MRC \<48/60
vasopressor dose modification	stabilization of ventilator settings ; 1hour after stabilization of ventilator settings	vasopressor dose in norepinephrine equivalent
change of the functional respiratory parameters from baseline at 6 months	at 6 months	vital capacity, total pulmonary capacity,
number of auto extubation	whatever until ICU discharge, an average 16 days
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)