Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

Learn more about:
Related Clinical Trial
Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Brief Title

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

Official Title

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study

Brief Summary

      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome. All patients entering the University Hospital
      of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the
      study groups at admission or the day before the operation.
    

Detailed Description

      Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in
      neurosurgical practice. The position of the proximal ventricular catheter is important since
      it influences possible malfunction of the VPS. For the improvement of accuracy in proximal
      VPS placement, navigation-based insertion techniques have been developed. VPS placement using
      stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS
      placement using stereotactic navigation has shown a high accuracy of catheter placement,
      while the main limitations are that for referencing, the head of the patient needs to be
      fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement
      using a burr hole probe was described as an alternate for image-guided VPS placement
      technique. For US-G VPS placement head fixation or preoperative registration is not needed.
      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome.
    


Study Type

Interventional


Primary Outcome

surgical intervention time (minutes)

Secondary Outcome

 Operation time (minutes)

Condition

Ventriculoperitoneal Shunt (VPS)

Intervention

US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

Study Arms / Comparison Groups

 US -G VPS placement
Description:  

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

Device

Estimated Enrollment

130

Start Date

February 26, 2020

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Informed Consent as documented by signature

          -  Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

        Exclusion Criteria:

          -  Revision surgery due to former VPS placement using the same side and location for VPS
             placement or when no complete shunt is revised (proximal and distal), resulting in a
             shorter operation time

          -  Ventriculoatrial or ventriculopleural Placement

          -  Women who are pregnant or breast feeding

          -  Intention to become pregnant during the course of the study

          -  Previous enrolment into the current study

          -  Enrolment of the investigator, his/her family members, employees, and other dependent
             persons
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Severina Leu, Dr. med., 0041 76 537 84 28, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT04450797

Organization ID

2019-02157; ch20Leu


Responsible Party

Sponsor

Study Sponsor

University Hospital, Basel, Switzerland


Study Sponsor

Severina Leu, Dr. med., Principal Investigator, Department of Neurosurgery, University Hospital of Basel


Verification Date

June 2020