Observing pressure management in patients with communicating hydrocephalus undergoing shunt surgery
A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Traffic Hydrocephalus Undergoing Lumbopeitoneal Shunt Surgery
RenJi Hospital · NCT06642129
This study looks at how pressure is managed in adults with communicating hydrocephalus who are having shunt surgery to see how it affects their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06642129 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients aged 18 and older who require lumboperitoneal shunt surgery for communicating hydrocephalus. It involves measuring lumbar puncture pressure before and during surgery, while also monitoring shunt valve pressure settings based on clinical practice. The study aims to collect data on various parameters, including preoperative and intraoperative pressures, shunt valve adjustments, and complications over a six-month period. The estimated sample size for this multicenter study is 30 cases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of communicating hydrocephalus who are eligible for lumboperitoneal shunt surgery.
Not a fit: Patients who are pregnant or deemed inappropriate for lumboperitoneal shunt surgery despite having communicating hydrocephalus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of shunt valve pressures, potentially leading to better outcomes for patients with communicating hydrocephalus.
How similar studies have performed: While similar studies have explored shunt management, this specific observational approach to pressure management in communicating hydrocephalus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Junfeng Feng Chief Director, MD，PhD
- Email: fengjfmail@163.com
- Phone: 86-13512193229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hydrocephalus, Communicating