NCT00636376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

6.8 years

First QC Date

March 11, 2008

Last Update Submit

October 20, 2008

Conditions

Head Injury

Keywords

elevated intracranial pressureinadequate cerebral perfusionsecondary brain damage

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

1

EXPERIMENTAL

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.

Interventions

Place HOB in alternate positions from 0-50 degrees.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

Also known as: Intracranial Pressure, Cerebral Venous Outflow, Head Elevation, Traumatic brain injury, Head injury
1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Neonates, children, and adolescents
  • Intracranial pressure monitor in place

You may not qualify if:

  • Severe multiorgan system failure
  • Hemodynamic instability sufficient to preclude changes in head position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial Hypertension

Interventions

Intracranial Pressure

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid PressureNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jimmy Huh, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

January 1, 2002

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)