Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation

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Brief Title

Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation

Official Title

Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation: Based on Patient Preoperative Imaging, EEG and Lumbar Tap Test

Brief Summary

      Patients with hydrocephalus are usually treated with cerebrospinal fluid (CFS) shunt to deal
      with excess cerebrospinal fluid in the brain. However, it is difficult to distinguish whether
      ventricular enlargement is due to hydrocephalus or other causes, such as brain injury and
      compensatory brain atrophy after surgery. Therefore, it is important to predict whether
      shunting will help patients. For this reason, clinicians must be cautious when treating
      patients with shunt therapy. Important assessments of the level of consciousness and
      continuous lumbar tap test are currently clinically common predictors before making decisions
      about CFS shunt therapy. However, for patients with serious disturbance of consciousness, it
      is difficult to predict the prognosis of surgery by observing the improvement of symptoms
      after lumbar tap test, which brings difficulties to the majority of clinical workers, and
      also easy to bring serious psychological and economic burden to patients.

      In clinical practice, clinicians still lack a stable and objective method to predict
      postoperative outcomes for these patients.

      In this clinical study, when participants performed the cerebrospinal fluid tap test to
      evaluate whether or not cerebrospinal fluid shunt was performed, various predictors that may
      be associated with CSF shunt outcomes before and after cerebrospinal fluid tap test were
      collected, including imaging data, EEG characteristics and changes in cerebrospinal fluid
      pressure. In addition, the researchers will collect the improvement of consciousness
      disturbance in patients with hydrocephalus before and after cerebrospinal fluid shunt, in
      order to explore the correlation between preoperative imaging data, EEG characteristics, the
      results of cerebrospinal fluid tap test and the improvement of consciousness disorders. A
      scheme of consciousness assessment based on the results of imaging, EEG and tap test results
      afte CSF tap test was proposed.
    

Detailed Description

      Among them, imaging parameters include:

      Evans index, EI; Callosal angle, CA; Z-Evans index, Z-EI; Brain/ventricle ratio, BVR; Frontal
      horn ratio, FHR; Frontal and occipital horn ratio, FOR/FOHR; Frontal and Temporal Horn Ratio,
      FTHR; Bicaudate ratio,BCR; Cella media ratio, CMR, etc. and the disorder of consciousness
      scales include: Coma recovery scale-Revised,CRS-R Glasgow-Pittsburgh cerebral performance
      categories Glasgow coma scale, GCS, etc.
    


Study Type

Interventional


Primary Outcome

Changes of consciousness disorder after operation


Condition

Disorder of Consciousness

Intervention

Cerebrospinal fluid shunt

Study Arms / Comparison Groups

 The patients did not respond to CSF tap test
Description:  Participants assigned to the experimental group did not respond to the CSF tap test and did not show improvement in general symptoms of hydrocephalus and disturbance of consciousness, but there may be changes in eeg and imaging parameters (it is unknown whether such changes are related to surgical outcome).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

April 10, 2022

Completion Date

December 10, 2022

Primary Completion Date

October 10, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18, gender is not limited.

          -  Patients with traffic hydrocephalus caused by various reasons, including atmospheric
             hydrocephalus, who need cerebrospinal fluid shunt and meet the surgical indications to
             a certain extent.

          -  Typical imaging manifestations of hydrocephalus patients.

          -  Clinical manifestations of consciousness disorder.

          -  Whether or not you can participate in the study will be decided after a doctor's
             examination.

        Exclusion Criteria:

          -  patients with mental or motor disorders, such as Alzheimer's disease, schizophrenia,
             and Parkinson's disease.

          -  Patients with abnormal coagulation mechanism or receiving treatment with thrombolysis
             agent, anticoagulant or platelet coagulant inhibitor and hemophilia.

          -  Patients with serious diseases of other systems, such as serious diseases of blood
             system, respiratory system, digestive system, urinary system and immune system, as
             well as patients with mental disorders and recent history of intracranial infection.

          -  Patients with a known disease causing ventricle enlargement.

          -  Female patients in pregnancy and lactation.

          -  Other circumstances in which the doctor judges that he cannot participate in the test.

          -  The subject himself or his legal representative refuses to participate in the clinical
             trial. Whether you are suitable to participate in this study needs the final decision
             after doctor's examination.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xiangrong Wang, bachelor, +8615070808607, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05237102

Organization ID

NanchangUZWang


Responsible Party

Sponsor-Investigator

Study Sponsor

Zhuohang Wang


Study Sponsor

Xiangrong Wang, bachelor, Principal Investigator, First affiliated hospital of Nanchang University


Verification Date

February 2022