Effects of Head Elevation on Intracranial Pressure in Children

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00636376
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 81
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head Injury	Procedure: Place HOB in alternate positions from 0-50 degrees.	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• 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
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

1. 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. [As long as ICP is being monitored.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00636376
• Other Study ID Numbers: 2002-1-2721
• First Posted: Mar 14, 2008
• Last Update Posted: Oct 21, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: elevated intracranial pressure; inadequate cerebral perfusion; secondary brain damage
• Additional relevant MeSH terms: Craniocerebral Trauma

Study Results

No Results Posted as of Oct 21, 2008