Effects of Head Elevation on Intracranial Pressure in Children

Head Injury Clinical Trial

Official title:

Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636376
• Other study ID #: 2002-1-2721
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: October 20, 2008
• Start date: January 2002
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head Injury

Intervention

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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No