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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04525482
Other study ID # 2017-081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2019

Study information

Verified date August 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary Richmond Agitation-Sedation Scale through study completion, an average of 2 year
Primary Mechanical ventilation time through study completion, an average of 2 year
Primary length of stay in ICU through study completion, an average of 2 year
Secondary complication through study completion, an average of 2 year
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