Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

Learn more about:
Related Clinical Trial
Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage 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

Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

Official Title

Multimodal Sonographic Monitoring of Cerebral Perfusion, Ventricle Seize and Optic Nerve Diameter During Weaning of Cerebrospinal Fluid Drainage Catheters: a Single Centre Observational Trial

Brief Summary

      As elaborated above only one study reported ultrasonographic changes of the width of the
      lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be
      suitable. No firm data exists about the change of the width of the third ventricle, the
      diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the
      width of these structures has been shown to depend on intracranial pressure. Ultrasonographic
      measurements of changes of the width of the third ventricle or the diameter of the optic
      nerve would have some advantages compared to the ultrasonographic assessments of the lateral
      ventricles. First, the width of the third ventricle can be measured easier and more reliable
      than the width of the lateral ventricles (better defined insonation plane and therefore
      higher repeatability of measurements) 3. Second, whereas assessments of the width of the side
      and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of
      patients have insufficient temporal bone windows), the measurement of the diameter of the
      optic nerve does not have this limitation and can therefore be performed in almost all
      patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one
      major limitation of transcranial ultrasound. The latter limitation for transcranial
      ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but
      this was also not yet studied. The use of an ultrasound contrast agent would in addition
      allow to study changes of brain perfusion during clamping of EVD/LD.
    

Detailed Description

      Background

      Placement of a CSF drainage catheter (external ventricular drainage (EVD) or lumbar drainage
      (LD)) is a frequent neurosurgical emergency intervention. It is used in case of obstructive
      hydrocephalus as it can occur after e.g. intracerebral hemorrhage with intraventricular
      involvement, subarachnoid hemorrhage or traumatic brain injury but also in situations with
      reduced CSF resorption or increased CSF production (e.g. meningitis, ventriculitis).
      Furthermore, this technique can be used to monitor intracranial pressure. In all these
      situations, the EVD/LD can be used to reduce the elevated intracranial pressure during the
      acute phase. However, because of impairment of the Paccioni granulations by blood and its
      breakdown products, a continuing hydrocephalus may develop, leading to permanent necessity of
      CSF drainage. To evaluate the need for a permanent (implanted) drainage system (e.g.
      ventriculoperitoneal or ventriculoatrial shunt) attempts to clamp the EVD/LD are carried out
      during the subacute phase. Successful clamping is verified by absent increase of intracranial
      pressure, absent clinical deterioration and lack of ventricular enlargement on serial CT
      scans. The latter means that a first CT scan has to be performed before clamping of the
      drainage catheter (baseline examination) and again 24 hours after clamping of the drainage
      catheter. This leads to the need for repeated transportations of critically ill patients with
      possible harm of the patient, high costs, need for more staff and repeated exposure of the
      patient to radiation. Hence, a simple, repeatable, non-invasive, bedside tool for diagnosis
      of ventricular enlargement due to clamping of EVD/LD is strongly needed.

      Transcranial ultrasound has become a widely used technique mainly for measuring arterial
      blood flow velocities. More recently, transcranial ultrasound has been also used to assess
      brain tissue, brain perfusion and ventricular size. The major advantages of ultrasound are
      its non-invasive character, the possibility for bedside application, low costs and safety (no
      X-ray exposure). Some studies have tried to use transcranial ultrasound for indirect
      assessment of intracranial pressure. As target structures for transcranial ultrasound either
      the lateral ventricles, the third ventricle or the diameter of the optic nerve were used. All
      studies could demonstrate a correlation between the width of the lateral or third ventricle
      or the diameter of the optic nerve with intracranial pressure. To the investigators'
      knowledge, only one study assessed the change of the width of the lateral ventricles during
      clamping of EVD/LD.

      To summarize, a bedside method for assessment of changes of ventricle width/diameter of the
      optic nerve during clamping of EVD/LD is urgently needed and would facilitate the procedure,
      higher patient safety and lower costs. By now, there are some promising ultrasound methods
      (transcranial ultrasound with or without contrast enhancing agent to determine the width of
      the side and third ventricle, diameter of the optic nerve), which might substitute repeated
      CT scans but have not been evaluated for monitoring clamping of EVD/LD.

      Objective

      The investigators hypothesize that clamping of EVD/LD can be monitored using repeated bedside
      ultrasound examinations instead of repeated CT scans. The purpose of this study is to
      investigate if a multimodal approach consisting of ultrasonographic determination of changes
      of the width of the third and the side ventricles as well as the diameter of the optic nerve
      can be used to screen for ventricle enlargement during clamping of EVD/LD. To this end, the
      investigators will compare a classifier based on ultrasound with the clinical decision based
      on CT.

      Methods

      The study consists of two additional ultrasonographic examinations . The standard treatment
      of patients undergoing clamping of EVD/LD is not affected by the study. The first
      ultrasonographic examination is performed in parallel to the baseline CT scan (either
      immediately before or after the CT scan) before clamping of the EVD/LD. The second ultrasound
      is made 24 hours after clamping of the EVD/LD in parallel to the follow-up CT Scan (either
      immediately before or after the CT scan). The examinations will be made bedside in the supine
      position on the ward where the patient is treated.
    


Study Type

Observational


Primary Outcome

binary classification of patients in terms of change of width of cerebrospinal fluid spaces by ultrasound

Secondary Outcome

 change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent

Condition

Hydrocephalus

Intervention

Sonographic monitoring

Study Arms / Comparison Groups

 All study participants
Description:  The study population consists of consecutive patients undergoing clamping of EVD/LD treated at the Departments of Neurosurgery or Intensive Care Medicine at the University Hospital Bern

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

Procedure

Estimated Enrollment

90

Start Date

September 2015

Completion Date

June 2024

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Informed consent of patient or relative and statement of independent physician

          -  Patient treated with EVD or LD undergoing clamping of EVD/LD

          -  Age ≥18 ≤ 80 years

        Exclusion Criteria

          -  Pregnancy and breastfeeding

          -  Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation),
             severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)

          -  Severe pulmonary or renal dysfunction

          -  Known allergy or adverse reaction to contrast material
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Werner Z'Graggen, MD, + 41 31 632 79 09, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT02408757

Organization ID

KEK 077/15


Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne


Study Sponsor

Werner Z'Graggen, MD, Principal Investigator, Department of Neurosurgery, University Hospital Bern


Verification Date

July 2022