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Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique

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ClinicalTrials.gov Identifier: NCT02775669
Recruitment Status : Unknown
Verified May 2016 by Bedjan Behmanesh, University Clinic Frankfurt.
Recruitment status was:  Enrolling by invitation
First Posted : May 17, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bedjan Behmanesh, University Clinic Frankfurt

Brief Summary:
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

Condition or disease
Hydrocephalus

Detailed Description:
The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
Study Start Date : January 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Group/Cohort
intracranial ICP monitoring
invasive intracranial ICP monitoring
tranfontanel ICP monitoring
Noninvasive transfontanel ICP monitoring



Primary Outcome Measures :
  1. Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe. [ Time Frame: 24 hours ]
    ICP values in mmHg will be collected in both arms



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study Population: Children with open fontanels and need of intracranial pressure monitoring
Criteria

Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring


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Responsible Party: Bedjan Behmanesh, MD, University Clinic Frankfurt
ClinicalTrials.gov Identifier: NCT02775669    
Other Study ID Numbers: 34/15
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Keywords provided by Bedjan Behmanesh, University Clinic Frankfurt:
noninvasive ICP monitoring
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases