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Application of Early Goal-directed Sedation in Patients With Severe Brain Injury

Primary Purpose

Brain Injuries, Traumatic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early goal-directed sedation programs
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Injuries, Traumatic focused on measuring Brain Injuries, Early Goal-directed Sedation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of severe craniocerebral injury
  • The GCS score is 6 to 12 points
  • Within 12 hours of intubation
  • The mechanical ventilation time is greater than 24 hours
  • Obtain written consent

Exclusion Criteria:

  • Pregnant women
  • Acute liver failure
  • Dementia or mental illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Intervention Group

    Arm Description

    No intervention was implemented

    Early goal-directed sedation programs was implemented

    Outcomes

    Primary Outcome Measures

    Richmond Agitation-Sedation Scale
    Mechanical ventilation time
    length of stay in ICU

    Secondary Outcome Measures

    complication

    Full Information

    First Posted
    August 18, 2020
    Last Updated
    August 20, 2020
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04525482
    Brief Title
    Application of Early Goal-directed Sedation in Patients With Severe Brain Injury
    Official Title
    Application of Early Goal-directed Sedation in Patients With Severe Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

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

    5. Study Description

    Brief Summary
    EGDS management strategy was implemented in ICU patients with severe brain injury, the depth of sedation and GCS score were monitored, and the protective effects of EGDS strategy and standard sedation strategy on the brain of patients with severe brain injury were discussed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries, Traumatic
    Keywords
    Brain Injuries, Early Goal-directed Sedation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No intervention was implemented
    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Early goal-directed sedation programs was implemented
    Intervention Type
    Other
    Intervention Name(s)
    Early goal-directed sedation programs
    Intervention Description
    A. Provide sedation at the beginning of the titration of dextrometomidine; b. Optimize sedation when dextrometomidine is used alone and at a maximum dose not sufficient to provide comfort and safety to the patient and to achieve a level of sedation at any time specified by the treating physician. C. Provides immediate recovery and sedation, and can control sudden agitation at any time
    Primary Outcome Measure Information:
    Title
    Richmond Agitation-Sedation Scale
    Time Frame
    through study completion, an average of 2 year
    Title
    Mechanical ventilation time
    Time Frame
    through study completion, an average of 2 year
    Title
    length of stay in ICU
    Time Frame
    through study completion, an average of 2 year
    Secondary Outcome Measure Information:
    Title
    complication
    Time Frame
    through study completion, an average of 2 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of severe craniocerebral injury The GCS score is 6 to 12 points Within 12 hours of intubation The mechanical ventilation time is greater than 24 hours Obtain written consent Exclusion Criteria: Pregnant women Acute liver failure Dementia or mental illness

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Application of Early Goal-directed Sedation in Patients With Severe Brain Injury

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