NCT03783468

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

December 11, 2018

Last Update Submit

March 14, 2022

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • oxygenation modification

    stabilization of ventilator settings; 1hour after stabilization of ventilator settings

  • arterial pressure modification

    stabilization of ventilator settings; 1hour after stabilization of ventilator settings

  • Heart rate modification

    stabilization of ventilator settings;1hour after stabilization of ventilator settings

  • vasopressor dose modification

    stabilization of ventilator settings ; 1hour after stabilization of ventilator settings

  • acquired neuromyopathy

    ICU discharge, an average 16 days

  • +6 more secondary outcomes

Study Arms (1)

light sedation pressure support ventilation

EXPERIMENTAL
Other: decrease of sedation doses and switch of ventilator settings

Interventions

decrease of sedation doses and switch of ventilator settingsOTHER

tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation

light sedation pressure support ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ARDS (Berlin definition)
  • social insurance

You may not qualify if:

  • neuromuscular disorders
  • pregnancy
  • need for muscular paralysis
  • need for deep neurosedation
  • more than 24hrs of artificial ventilation
  • cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Geoffrey Ledoux, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 21, 2018

Study Start

December 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 17, 2022

Record last verified: 2022-03