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

May 17, 2016 updated by: Bedjan Behmanesh, University Clinic Frankfurt
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population: Children with open fontanels and need of intracranial pressure monitoring

Description

Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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