Head InjuryNCT00636376
Effects of Head Elevation on Intracranial Pressure in Children
A study testing Place HOB in alternate positions from 0-50 degrees. in people with Head Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Head Injury
- What is being tested?
- Place HOB in alternate positions from 0-50 degrees.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Neonates, children, and adolescents
- Intracranial pressure monitor in place
Who cannot join
- Severe multiorgan system failure
- Hemodynamic instability sufficient to preclude changes in head position
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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
- Being tested
- Place HOB in alternate positions from 0-50 degrees.
- Keywords
- elevated intracranial pressure, inadequate cerebral perfusion, secondary brain damage
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Place HOB in alternate positions from 0-50 degrees.Procedure or surgery
Also called Intracranial Pressure, Cerebral Venous Outflow, Head Elevation, Traumatic brain injury
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Place HOB in alternate positions from 0-50 degrees. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: As long as ICP is being monitored.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJan 2002
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Investigators
- Jimmy Huh, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636376
- Sponsor's protocol ID
- 2002-1-2721
- Status last verified
- Oct 2008
- First submitted
- 11 Mar 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Elevation on Intracranial Pressure and Cerebral Venous Outflow in Children
- ClinicalTrials.gov ID
- NCT00636376
- Acronym / sponsor ID
- 2002-1-2721
- Conditions
- Head Injury
- Keywords
- elevated intracranial pressure, inadequate cerebral perfusion, secondary brain damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Place HOB in alternate positions from 0-50 degrees.Single arm--no randomization. All subjects enrolled will have vitals collected and three ultrasounds at different levels of head of the bed elevations. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Neonates, children, and adolescents
- Intracranial pressure monitor in place
Key exclusion criteria (2 listed)
- Severe multiorgan system failure
- Hemodynamic instability sufficient to preclude changes in head position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Place HOB in alternate positions from 0-50 degrees.Also: Intracranial Pressure, Cerebral Venous Outflow, Head Elevation, Traumatic brain injuryPatients 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 | Procedure or surgery | 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Head Injury
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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Nanopulse Laser Therapy
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RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Huh, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Place HOB in alternate positions from 0-50 degrees. in people with Head Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.