Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 10, 2016
First Posted Date May 17, 2016
Last Update Posted Date May 18, 2016
Study Start Date January 2015
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2016)
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
Original Primary Outcome Measures
 (submitted: May 16, 2016)
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: 1 year ]
ICP values in mmHg will be collected in both arms
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study Population: Children with open fontanels and need of intracranial pressure monitoring
Condition Hydrocephalus
Intervention Not Provided
Study Groups/Cohorts
  • intracranial ICP monitoring
    invasive intracranial ICP monitoring
  • tranfontanel ICP monitoring
    Noninvasive transfontanel ICP monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 16, 2016)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring

Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02775669
Other Study ID Numbers 34/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bedjan Behmanesh, University Clinic Frankfurt
Study Sponsor University Clinic Frankfurt
Collaborators Not Provided
Investigators Not Provided
PRS Account University Clinic Frankfurt
Verification Date May 2016