LIght Sedation Pressure Support (LIPS)

Early LIght Sedation Pressure Support in ARDS Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: ARDS, Human
• Intervention / Treatment: Other: decrease of sedation doses and switch of ventilator settings

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Geoffrey Ledoux, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: 2017_18; 2018-A01036-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No