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LIght Sedation Pressure Support (LIPS)

Primary Purpose

ARDS, Human

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
decrease of sedation doses and switch of ventilator settings
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    light sedation pressure support ventilation

    Arm Description

    Outcomes

    Primary Outcome Measures

    transpulmonary pressure at early stabilization of patient
    transpulmonary pressure (Paw - Peso < 24 cmH2O)

    Secondary Outcome Measures

    oxygenation modification
    PaO2/FiO2
    arterial pressure modification
    Mean arterial pressure
    Heart rate modification
    heart rate
    vasopressor dose modification
    vasopressor dose in norepinephrine equivalent
    acquired neuromyopathy
    MRC <48/60
    muscular volume decrease
    quadriceps volume assessed by echography
    ventilator free days
    ventilator free days until day 28
    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.
    change of the functional respiratory parameters from baseline at 6 months
    vital capacity, total pulmonary capacity,
    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)
    number of auto extubation

    Full Information

    First Posted
    December 11, 2018
    Last Updated
    March 14, 2022
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03783468
    Brief Title
    LIght Sedation Pressure Support
    Acronym
    LIPS
    Official Title
    Early LIght Sedation Pressure Support in ARDS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    decision
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ARDS, Human

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    light sedation pressure support ventilation
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    decrease of sedation doses and switch of ventilator settings
    Intervention Description
    tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation
    Primary Outcome Measure Information:
    Title
    transpulmonary pressure at early stabilization of patient
    Description
    transpulmonary pressure (Paw - Peso < 24 cmH2O)
    Time Frame
    when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
    Secondary Outcome Measure Information:
    Title
    oxygenation modification
    Description
    PaO2/FiO2
    Time Frame
    stabilization of ventilator settings; 1hour after stabilization of ventilator settings
    Title
    arterial pressure modification
    Description
    Mean arterial pressure
    Time Frame
    stabilization of ventilator settings; 1hour after stabilization of ventilator settings
    Title
    Heart rate modification
    Description
    heart rate
    Time Frame
    stabilization of ventilator settings;1hour after stabilization of ventilator settings
    Title
    vasopressor dose modification
    Description
    vasopressor dose in norepinephrine equivalent
    Time Frame
    stabilization of ventilator settings ; 1hour after stabilization of ventilator settings
    Title
    acquired neuromyopathy
    Description
    MRC <48/60
    Time Frame
    ICU discharge, an average 16 days
    Title
    muscular volume decrease
    Description
    quadriceps volume assessed by echography
    Time Frame
    at 24 hours; at day of extubation; ICU discharge, an average 16 days
    Title
    ventilator free days
    Description
    ventilator free days until day 28
    Time Frame
    during the first 28 days
    Title
    delirium in ICU
    Description
    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.
    Time Frame
    ICU discharge, an average 16 days
    Title
    change of the functional respiratory parameters from baseline at 6 months
    Description
    vital capacity, total pulmonary capacity,
    Time Frame
    at 6 months
    Title
    PTSD
    Description
    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)
    Time Frame
    at 6 months
    Title
    number of auto extubation
    Time Frame
    whatever until ICU discharge, an average 16 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Geoffrey Ledoux, MD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    LIght Sedation Pressure Support

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