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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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