- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636376
Effects of Head Elevation on Intracranial Pressure in Children
October 20, 2008 updated by: Children's Hospital of Philadelphia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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As long as ICP is being monitored.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jimmy Huh, MD, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
March 11, 2008
First Submitted That Met QC Criteria
March 13, 2008
First Posted (Estimate)
March 14, 2008
Study Record Updates
Last Update Posted (Estimate)
October 21, 2008
Last Update Submitted That Met QC Criteria
October 20, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-1-2721
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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