NCT02027857

Brief Summary

Brain edema is the main reason for the disability and lethality in traumatic brain injury, which is the most difficult part of emergency rescue. Recently, there is no medical equipment to monitor the early brain edema in clinic. We have found that Electrical impedance tomography (EIT) can perform the real-time and bedside monitoring of brain electrical impedance after single-dose mannitol treatment, which may be a new strategy for the surveillance of brain edema. In this study, we would like to compare the application in traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring, including the progress of brain edema, the relationship between impedance and ICP, and the improvement for the patients' prognosis. EIT would probably be a new image strategy for the treatment of traumatic brain injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

December 23, 2013

Last Update Submit

January 2, 2014

Conditions

Brain Electrical Impedance;Non-invasive Intracranial Pressure

Keywords

brain electrical impedance;traumatic brain injury;brain edema;intracranial pressure

Outcome Measures

Primary Outcomes (1)

  • brain electrical impedance

    After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.

    From the 1st day (enrollment) to the 7th day

Secondary Outcomes (9)

  • Glasgow coma scale(GCS)

    on the 0 day of the study

  • demographic characteristics at baseline

    on the 0 day of the study

  • kidney function examination

    On the 1st day, 3rd day, 5th and 7th day

  • Physiological and pathological reflex check

    on the 1st and 7th day

  • muscular strength and tension test

    on the 1st and 7th day

  • +4 more secondary outcomes

Study Arms (3)

mannitol empirical therapy

NO INTERVENTION

There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the empirical therapy by doctors.

EIT monitoring

EXPERIMENTAL

There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of Electrical impedance tomography monitoring.

Device: EIT monitoring

non-invasive ICP monitoring

OTHER

There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of non-invasive intracranial pressure monitoring.

Device: non-invasive ICP monitoring

Interventions

EIT monitoringDEVICE
EIT monitoring
non-invasive ICP monitoringDEVICE
non-invasive ICP monitoring

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients were 16 to 65 years of age with all genders.
  • The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
  • All the patients had provided written informed consent.
  • \. The patients were receiving usual inpatient rehabilitation and conservative treatment .

You may not qualify if:

  • The patients with indication of operation during the research should be excluded.
  • The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Edema

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fei Zhou, M.D.; Ph.D.

    Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Hu Shijie, M.D;Ph.D.

CONTACT

086-29-84773307hushijie@fmmu.edu.cn

Hu Shijie, M.D;Ph.D.

CONTACT

086-13992888996hushijie1979@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 6, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

CN(1)