Effects of Head Elevation on Intracranial Pressure in Children

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00636376
First received: March 11, 2008
Last updated: October 20, 2008
Last verified: October 2008

March 11, 2008
October 20, 2008
January 2002
October 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00636376 on ClinicalTrials.gov Archive Site
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Effects of Head Elevation on Intracranial Pressure in Children
Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Head Injury
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
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636376
2002-1-2721
No
Jimmy Huh, MD, The Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Jimmy Huh, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
October 2008

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