Effects of Head Elevation on Intracranial Pressure in Children

NCT ID: NCT00636376

Last Updated: 2008-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2008-10-31

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.

Conditions

Head Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Single arm--no randomization. All subjects enrolled will have vitals collected and three ultrasounds at different levels of head of the bed elevations.

Group Type: EXPERIMENTAL

Place HOB in alternate positions from 0-50 degrees.

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Intracranial Pressure; Cerebral Venous Outflow; Head Elevation; Traumatic brain injury; Head injury

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

The Children's Hospital of Philadelphia

Principal Investigators

Jimmy Huh, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2002-1-2721

Identifier Type: -

Identifier Source: org_study_id