Effects of Head Elevation on Intracranial Pressure in Children
Primary Purpose
Head Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Place HOB in alternate positions from 0-50 degrees.
Sponsored by
About this trial
This is an interventional prevention trial for Head Injury focused on measuring elevated intracranial pressure, inadequate cerebral perfusion, secondary brain damage
Eligibility 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
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Single arm--no randomization. All subjects enrolled will have vitals collected and three ultrasounds at different levels of head of the bed elevations.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00636376
First Posted
March 11, 2008
Last Updated
October 20, 2008
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00636376
Brief Title
Effects of Head Elevation on Intracranial Pressure in Children
Official Title
Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
Keywords
elevated intracranial pressure, inadequate cerebral perfusion, secondary brain damage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Single arm--no randomization. All subjects enrolled will have vitals collected and three ultrasounds at different levels of head of the bed elevations.
Intervention Type
Procedure
Intervention Name(s)
Place HOB in alternate positions from 0-50 degrees.
Other Intervention Name(s)
Intracranial Pressure, Cerebral Venous Outflow, Head Elevation, Traumatic brain injury, Head injury
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Huh, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Effects of Head Elevation on Intracranial Pressure in Children
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