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Effects of Head Elevation on Intracranial Pressure in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636376
First Posted: March 14, 2008
Last Update Posted: October 21, 2008
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.
Information provided by:
Children's Hospital of Philadelphia
  Purpose
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.

Condition Intervention
Head Injury Procedure: Place HOB in alternate positions from 0-50 degrees.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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. ]

Enrollment: 18
Study Start Date: January 2002
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636376


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jimmy Huh, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: Jimmy Huh, MD, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00636376     History of Changes
Other Study ID Numbers: 2002-1-2721
First Submitted: March 11, 2008
First Posted: March 14, 2008
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by Children's Hospital of Philadelphia:
elevated intracranial pressure
inadequate cerebral perfusion
secondary brain damage

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries