NCT04525482

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

August 18, 2020

Last Update Submit

August 20, 2020

Conditions

Brain Injuries, Traumatic

Keywords

Brain InjuriesEarly Goal-directed Sedation

Outcome Measures

Primary Outcomes (3)

  • Richmond Agitation-Sedation Scale

    through study completion, an average of 2 year

  • Mechanical ventilation time

    through study completion, an average of 2 year

  • length of stay in ICU

    through study completion, an average of 2 year

Secondary Outcomes (1)

  • complication

    through study completion, an average of 2 year

Study Arms (2)

Control Group

NO INTERVENTION

No intervention was implemented

Intervention Group

EXPERIMENTAL

Early goal-directed sedation programs was implemented

Other: Early goal-directed sedation programs

Interventions

Early goal-directed sedation programsOTHER

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

Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 25, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share