A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Communicating Hydrocephalus Undergoing Lumboperitoneal Shunt Surgery

Recruiting

• Conditions: Hydrocephalus, Communicating

• Registration Number: NCT06642129
• Lead Sponsor: RenJi Hospital

Brief Summary

Target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus Estimated sample size: 30 cases. Study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. Complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age of 18 years or older;
2. Confirmed diagnosis of communicating hydrocephalus;
3. Signed informed consent for surgery and informed consent for research.

Exclusion Criteria

1. Pregnant women;
2. Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary outcome	preoperation to 6 months after surgery	1. Measurement of preoperative bedside lumbar puncture pressure(cmH2O); 2. Measurement of lumbar puncture pressure after anesthesia during lumboperitoneal shunt surgery(cmH2O) ; 3. Initial setting of shunt valve; 4. Setting of shunt valve at 6 months after lumboperitoneal shunt surgery

Secondary Outcome Measures

Name	Time	Method
secondary outcome	preoperation to 6 months after surgery	The numbers of complications related to the lumboperitoneal shunt at 6 months after the shunt operation, including: subdural hemorrhage, ventricular hemorrhage, intracerebral hemorrhage, subdural effusion, shunt obstruction, resetting the shunt, intracranial infection, and epilepsy.

Trial Locations

Locations (1)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China