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

August 20, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention was implemented
Experimental: Intervention Group
Early goal-directed sedation programs was implemented
Other: Early goal-directed sedation programs
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Richmond Agitation-Sedation Scale
Time Frame: through study completion, an average of 2 year
through study completion, an average of 2 year
Mechanical ventilation time
Time Frame: through study completion, an average of 2 year
through study completion, an average of 2 year
length of stay in ICU
Time Frame: through study completion, an average of 2 year
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
complication
Time Frame: through study completion, an average of 2 year
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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