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Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

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ClinicalTrials.gov Identifier: NCT02408757
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment
Hydrocephalus Procedure: Sonographic monitoring

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All study participants
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
Procedure: Sonographic monitoring
Sonographic monitoring during weaning of cerebrospinal fluid drainage catheters




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  2. change of width of the third ventricle measured with transcranial ultrasound with ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  3. change of width of the lateral ventricles measured with transcranial ultrasound without ultrasound contrast agent [ Time Frame: 24 hours after clamping of EVD/LD ]
  4. change of diameter of the optic nerve [ Time Frame: 24 hours after clamping of EVD/LD ]
  5. change of width of the third ventricle in the CT scan [ Time Frame: 24 hours after clamping of EVD/LD ]
  6. change of width of the lateral ventricles in the CT scan [ Time Frame: 24 hours after clamping of EVD/LD ]
  7. change of brain perfusion in the brain regions adjacent to the third ventricle [ Time Frame: 24 hours after clamping of EVD/LD ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408757


Contacts
Contact: Werner Z`Graggen, MD + 41 31 632 79 09 werner.zgraggen@insel.ch
Contact: Jürgen Beck +41 31 632 00 14 juergen.beck@insel.ch

Locations
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Werner Z`Graggen, MD    +41 31 632 79 09    werner.zgraggen@insel.ch   
Contact: Jürgen Beck, MD    +41 31 632 00 14    juergen.beck@insel.ch   
Principal Investigator: Werner Z`Graggen, MD         
Sub-Investigator: Jürgen Beck, MD         
Sub-Investigator: Sonja Vulcu, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Werner Z`Graggen, MD Department of Neurosurgery, University Hospital Bern

Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02408757     History of Changes
Other Study ID Numbers: KEK 077/15
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by University Hospital Inselspital, Berne:
ultrasound
cerebral perfusion
cerebrospinal fluid drainage

Additional relevant MeSH terms:
Hydrocephalus
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries