Clinical Trial: Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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 ul
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: binary classification of patients in terms of change of width of cerebrospinal fluid spaces by ultrasound [ Time Frame: 24 hours after clamping of EVD/LD ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of width of the third ventricle measured with transcranial ultrasound with ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of width of the lateral ventricles measured with transcranial ultrasound without ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of diameter of the optic nerve [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of width of the third ventricle in the CT scan [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of width of the lateral ventricles in the CT scan [ Time Frame: 24 hours after clamping of EVD/LD ]
  • change of brain perfusion in the brain regions adjacent to the third ventricle [ Time Frame: 24 hours after clamping of EVD/LD ]


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: March 31, 2015
Date Started: September 2015
Date Completion: October 2017
Last Updated: January 11, 2017
Last Verified: January 2017