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

NCT05237102 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-02-23

No results posted yet for this study

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.

Conditions

  • Disorder of Consciousness
  • Hydrocephalus

Interventions

PROCEDURE

Cerebrospinal fluid shunt

The procedure is designed to reduce the amount of cerebrospinal fluid in a patient's brain by draining it through a shunt tube: ①V-P shunt is suitable for most types of hydrocephalus; ②L-P shunt is suitable for traffic hydrocephalus and positive pressure hydrocephalus, and patients with lower cerebellar tonsil hernia are contraindications; ③ Common terms of ventriculoatrial (V-A) shunt are not suitable for V-P shunt (abdominal infection, serious respiratory and circulatory diseases are contraindications); ④ The third ventriculostomy is suitable for patients with non-traffic and partial traffic hydrocephalus (infants and patients with severe ventricular enlargement should be cautious, and patients with shunt tube cannot be placed due to ventricular conditions); ⑤Other shunt methods include septum pellucidum fistula and Torshunt (ventriculo-occipital cistern shunt after tumor resection)

Sponsors & Collaborators

  • Zhuohang Wang

    lead OTHER

Principal Investigators

  • Xiangrong Wang, bachelor · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2022-10-10
Completion
2022-12-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05237102 on ClinicalTrials.gov