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

NCT06642129 | Recruiting

• 1 other identifier: LY2024-070-B
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus, Communicating

Outcome Measures

Primary Outcomes (1)

• primary outcome

  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

  preoperation to 6 months after surgery

Secondary Outcomes (1)

• secondary outcome

  preoperation to 6 months after surgery

Study Arms (1)

Oberservation Group

Patient requiring surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Interventions

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines PROCEDURE

Lumboperitoneal shunt (LPS) involves connecting the subarachnoid space of the lumbar spine to the peritoneal cavity through a pressure-adjustable unidirectional valve to shunt the appropriate amount of cerebrospinal fluid from the ventricles to the peritoneal cavity via the spinal canal, where it is absorbed through the peritoneum, to alleviate the increased intracranial pressure caused by the communicating hydrocephalus and the corresponding clinical symptoms.

Oberservation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 years of age and older who require surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Junfeng Feng Chief Director, MD，PhD

CONTACT

86-13512193229; fengjfmail@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director of Brain Injury Center

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-09

Locations

CN (1)