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Effects of Head Elevation on Intracranial Pressure in Children

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ClinicalTrials.gov Identifier: NCT00636376
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE March 11, 2008
First Posted Date  ICMJE March 14, 2008
Last Update Posted Date October 21, 2008
Study Start Date  ICMJE January 2002
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
ICP will be reduced with improvement in cerebral venous outflow which is dependent on intravascular volume status and intrathoracic pressure and each will have their own optimal head position. [ Time Frame: As long as ICP is being monitored. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Head Elevation on Intracranial Pressure in Children
Official Title  ICMJE Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children
Brief Summary Head injury is the most common cause of mortality and acquired disability in childhood. It is common to elevate the head of patients at risk for increased intracranial pressure, although it is not clear if it is always beneficial. Every severe pediatric traumatic brain injured patient will have an optimal head position that prevents rising pressure in the brain.
Detailed Description Head injury is the most common cause of mortality and acquired disability on childhood. Management of children at risk for intracranial hypertension is both complex and increasingly controversial. Also, effect of head position on intracranial pressure, cerebral perfusion pressure, adn cerebral venous outflow in the pediatric population has not been studied. We will examine the effect of head positioning on ICP, CPP, and cerebral venous outflow in pediatric patients at risk for intracranial hypertension. The hypothesis is that ICP will be reduced with improvement in cerebral venous outflow by each patient having their own optimal head position.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Head Injury
Intervention  ICMJE Procedure: Place HOB in alternate positions from 0-50 degrees.
Patients will receive an US while the HOB(Elevation of the head of bed) is 30 degrees(baseline) then they will increase the angle to 40 degrees, then 50 degrees. Another US will be done then in 20, 10, and o degree angles. Then another US will be done
Other Names:
  • Intracranial Pressure
  • Cerebral Venous Outflow
  • Head Elevation
  • Traumatic brain injury
  • Head injury
Study Arms  ICMJE Experimental: 1
Single arm--no randomization. All subjects enrolled will have vitals collected and three ultrasounds at different levels of head of the bed elevations.
Intervention: Procedure: Place HOB in alternate positions from 0-50 degrees.
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2008)
20
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Neonates, children, and adolescents
  • Intracranial pressure monitor in place

Exclusion Criteria:

  • Severe multiorgan system failure
  • Hemodynamic instability sufficient to preclude changes in head position
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636376
Other Study ID Numbers  ICMJE 2002-1-2721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jimmy Huh, MD, The Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jimmy Huh, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP