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

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Brief Title

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

Official Title

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

Brief Summary

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

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.
    


Study Type

Observational


Primary Outcome

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.


Condition

Hydrocephalus


Study Arms / Comparison Groups

 intracranial ICP monitoring
Description:  invasive intracranial ICP monitoring

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

10

Start Date

January 2015

Completion Date

December 2017

Primary Completion Date

April 2017

Eligibility Criteria

        Inclusion Criteria:

        Child with open fontanel Need of ICP monitoring

        Exclusion Criteria:

        closed fontanel No Need of ICP monitoring
      

Gender

All

Ages

1 Day - 15 Months

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02775669

Organization ID

34/15


Responsible Party

Principal Investigator

Study Sponsor

University Clinic Frankfurt


Study Sponsor

, , 


Verification Date

May 2016