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Register:	ClinicalTrials.gov
Last refreshed on:	11 December 2023
Main ID:	NCT02408757
Date of registration:	31/03/2015
Prospective Registration:	Yes
Primary sponsor:	Insel Gruppe AG, University Hospital Bern
Public title:	Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
Scientific 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
Date of first enrolment:	September 2015
Target sample size:	44
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT02408757
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Switzerland

Contacts

Name:	Werner Z'Graggen, MD
Address:
Telephone:
Email:
Affiliation:	Department of Neurosurgery, University Hospital Bern

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hydrocephalus

Intervention(s)

Procedure: Sonographic monitoring

Primary Outcome(s)

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(s)

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 brain perfusion in the brain regions adjacent to the third ventricle [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 lateral ventricles in the CT scan [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 third ventricle measured with transcranial ultrasound with ultrasound contrast agent [Time Frame: 24 hours after clamping of EVD/LD]

change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent [Time Frame: 24 hours after clamping of EVD/LD]

Secondary ID(s)

KEK 077/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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