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

University Clinic Frankfurt10 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hydrocephalus

Eligibility

Sex: ALLMin age: 1 DayMax age: 15 Months

Medical Language ↔ Plain English

Inclusion Criteria: Child with open fontanel Need of ICP monitoring Exclusion Criteria: closed fontanel No Need of ICP monitoring

Outcomes

Primary Outcomes

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.

ICP values in mmHg will be collected in both arms

Time frame: 24 hours

Data from ClinicalTrials.gov

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