LIght Sedation Pressure Support

ARDS, Human Clinical Trial

— LIPS  

Official title:

Early LIght Sedation Pressure Support in ARDS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03783468
• Other study ID #: 2017_18
• Secondary ID: 2018-A01036-49
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Other:
• decrease of sedation doses and switch of ventilator settings
tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

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