Traumatic Brain InjuryNCT00194441
Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing
A study testing Bedside display of cerebral perfusion pressure information in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Washington at 1 site in United States.
Trial summary
The aim of the initial proposal was to evaluate, in the context of optimal medical management, the impact of a bedside system of cerebral perfusion pressure (CPP) information feedback on nursing moment-to-moment management of CPP, and the relationship of that management to patient functional outcome at discharge, 3… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- What is being tested?
- Bedside display of cerebral perfusion pressure information
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic brain injury or subarachnoid hemorrhage
- Age 16 years or older
- Admitted to intensive care unit
- Invasive intracranial pressure and arterial blood pressure monitoring
Who cannot join
- Impending death
- Inclusion Criteria for second phase of study (determination of CPP threshold in children):
- Traumatic brain injury
- Age 15 years or younger
- Able to communicate by telephone
- Admitted to intensive care unit
Show all 10Show fewer
- Intracranial pressure monitoring
- Inclusion Criteria for second phase of study (quality adjusted life years assessment):
- Hospitalized for a traumatic brain injury or subarachnoid hemorrhage at an academic medical center within the last 10 years
- Age 18 years or older at the time of hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CPP Management Information Feedback and Nursing
The aim of the initial proposal was to evaluate, in the context of optimal medical management, the impact of a bedside system of cerebral perfusion pressure (CPP) information feedback on nursing moment-to-moment management of CPP, and the relationship of that management to patient functional outcome at discharge, 3 and 6 months. The primary hypothesis being tested is that Glasgow Outcome Score (GOS) 6 months post acute care discharge will be significantly better in those monitored with the continuous CPP display.
In the second phase of the study the adult study will be extended to children to determine if there is a critical threshold for CPP in children following brain injury based on their outcome at 3, 6, and 12 months. The primary outcome measure is the GOS at 12 months post-injury. The GOS, Behavior Rating Inventory of Executive Function, and PedsQOL will also be assessed at 3, 6, \& 12 months, and the Adaptive Behavior Assessment System at 3 and 6 months post-injury. In addition, the researchers will examine variability and complexity of physiologic measures, such as blood pressure, recorded during the intensive care unit stay of adults and children enrolled in the study. The researchers will study the association of these measures with risk for secondary brain injury and ability to predict differences in outcome. The researchers will also assess the value individuals place on varying outcomes following brain injury.
Read the detailed description
Prevention or reduction of secondary brain injury is a key component in the critical care management of patients with a variety of brain insults. Current clinical management emphasizes maintaining cerebral perfusion pressure (CPP) at or above 70 mm Hg to minimize such secondary brain injury. However, due to poor ergonomics in clinical monitoring displays it is likely that short episodes of decreased CPP are missed by attending nurses in the course of necessary patient repositioning, suctioning, and other routine therapeutic activities. Given the crucial role of neuronal perfusion in preventing secondary injury beyond that of the original brain insult, refining the nurse's ability to visualize and manage CPP on a moment-to-moment basis may allow measurable improvement in short and long-term patient functional outcome. Computer interfaces that provide highly visible information about CPP will be randomly allocated to intensive care unit beds of patients with closed head injury (CHI) or subarachnoid hemorrhage (SAH) in whom intracranial pressure monitors and arterial lines have been placed for medical management, stratified by primary diagnosis (CHI or SAH) and severity. Continuous data will be collected from 150 patients with and 150 patients without the interface monitor for the duration of CPP monitoring. The primary hypothesis being tested is that the Glasgow Outcome Score (GOS) 6 months after acute care discharge will be significantly better in those monitored with the continuous CPP display. Secondary endpoints are GOS at discharge and 3 months after discharge, Functional Independence Measure (FIM) score at discharge, and the Functional Status examination at 3 and 6 months. The percentage of CPP below set levels during hospital monitoring will be determined.
No CPP thresholds have been established that adequately predict how well children who survive a brain injury will do. Thus we will describe the association between various CPP thresholds and children's outcome up to one year after their brain injury. The target number of children to be enrolled is 65.
Studies suggest that the regularity or variability of physiologic measures, for example, heart rate, may give information about how well the system can respond to challenges. Changes in variability may be associated with disease. Describing physiologic variability may therefore be useful to identify critically ill individuals with brain injury who are less able to adapt to challenges and may be a greater risk for further brain injury and poorer outcome.
Measures of the value that individuals place on the various health states are used to calculate quality adjusted life years and assess the cost-effectiveness of treatments. While measures have been developed to assess how individuals value different outcomes, information regarding the value placed on outcomes following brain injury is lacking. We will use these measures to carry out interviews of both brain injury survivors and those who have not had a brain injury to add to the knowledge in this area.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Being tested
- Bedside display of cerebral perfusion pressure information
- Keywords
- cerebral circulation, monitoring, physiologic, informatics, nursing care, physiologic variability, outcome, quality adjusted life years
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside display of cerebral perfusion pressure informationOther
Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Highly visible continually updating color coded bar computer display of cerebral perfusion pressure. Receives: Other: Bedside display of cerebral perfusion pressure information |
| 2 | Placebo comparator | Bedside computer display with a blank screen except for a message indicating that the program is running. Receives: Other: Bedside display of cerebral perfusion pressure information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale
Measured: Six month follow-up
Secondary outcomes (4)
Glasgow Outcome Scale
Measured: Hospital discharge and three month follow-up
Functional Status Examination
Measured: Three and six-month follow-up
SF-36 Quality of Life
Measured: Six month follow-up
Patient Competency Rating Scale
Measured: Six month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 1999
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Catherine Kirkness, University of Washington
- Investigators
- Catherine J Kirkness, PhD, Principal investigator, University of WashingtonPamela H Mitchell, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194441
- Sponsor's protocol ID
- 14622-C
- Other IDs
- 5R01NR004901-07
- Status last verified
- May 2014
- First submitted
- 12 Sep 2005
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mitchell PH, Burr RL, Kirkness CJ. Information technology and CPP management in neuro intensive care. Acta Neurochir Suppl. 2002;81:163-5. doi: 10.1007/978-3-7091-6738-0_42.
PubMed 12168293Kirkness CJ, Burr RL, Mitchell PH, Newell DW. Is there a sex difference in the course following traumatic brain injury? Biol Res Nurs. 2004 Apr;5(4):299-310. doi: 10.1177/1099800404263050.
PubMed 15068659Kirkness CJ, Thompson JM, Ricker BA, Buzaitis A, Newell DW, Dikmen S, Mitchell PH. The impact of aneurysmal subarachnoid hemorrhage on functional outcome. J Neurosci Nurs. 2002 Jun;34(3):134-41. doi: 10.1097/01376517-200206000-00006.
PubMed 12080869Kirkness CJ, Burr RL, Cain KC, Newell DW, Mitchell PH. Effect of continuous display of cerebral perfusion pressure on outcomes in patients with traumatic brain injury. Am J Crit Care. 2006 Nov;15(6):600-9; quiz 610.
PubMed 17053267Kirkness CJ, Burr RL, Cain KC, Newell DW, Mitchell PH. Relationship of cerebral perfusion pressure levels to outcome in traumatic brain injury. Acta Neurochir Suppl. 2005;95:13-6. doi: 10.1007/3-211-32318-x_3.
PubMed 16463811Kirkness CJ, Burr RL, Thompson HJ, Mitchell PH. Temperature rhythm in aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2008;8(3):380-90. doi: 10.1007/s12028-007-9034-y.
PubMed 18066502Thompson HJ, Kirkness CJ, Mitchell PH. Intensive care unit management of fever following traumatic brain injury. Intensive Crit Care Nurs. 2007 Apr;23(2):91-6. doi: 10.1016/j.iccn.2006.11.005. Epub 2007 Jan 12.
PubMed 17223560
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPP Management Information Feedback and Nursing
- ClinicalTrials.gov ID
- NCT00194441
- Acronym / sponsor ID
- 14622-C
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Keywords
- cerebral circulation, monitoring, physiologic, informatics, nursing care, physiologic variability, outcome, quality adjusted life years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 1999
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Sep 2005 (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.
The aim of the initial proposal was to evaluate, in the context of optimal medical management, the impact of a bedside system of cerebral perfusion pressure (CPP) information feedback on nursing moment-to-moment management of CPP, and the relationship of that management to patient functional outcome at discharge, 3 and 6 months. The primary hypothesis being tested is that Glasgow Outcome Score (GOS) 6 months post acute care discharge will be significantly better in those monitored with the continuous CPP display.
In the second phase of the study the adult study will be extended to children to determine if there is a critical threshold for CPP in children following brain injury based on their outcome at 3, 6, and 12 months. The primary outcome measure is the GOS at 12 months post-injury. The GOS, Behavior Rating Inventory of Executive Function, and PedsQOL will also be assessed at 3, 6, \& 12 months, and the Adaptive Behavior Assessment System at 3 and 6 months post-injury. In addition, the researchers will examine variability and complexity of physiologic measures, such as blood pressure, recorded during the intensive care unit stay of adults and children enrolled in the study. The researchers will study the association of these measures with risk for secondary brain injury and ability to predict differences in outcome. The researchers will also assess the value individuals place on varying outcomes following brain injury.
Detailed description
Prevention or reduction of secondary brain injury is a key component in the critical care management of patients with a variety of brain insults. Current clinical management emphasizes maintaining cerebral perfusion pressure (CPP) at or above 70 mm Hg to minimize such secondary brain injury. However, due to poor ergonomics in clinical monitoring displays it is likely that short episodes of decreased CPP are missed by attending nurses in the course of necessary patient repositioning, suctioning, and other routine therapeutic activities. Given the crucial role of neuronal perfusion in preventing secondary injury beyond that of the original brain insult, refining the nurse's ability to visualize and manage CPP on a moment-to-moment basis may allow measurable improvement in short and long-term patient functional outcome. Computer interfaces that provide highly visible information about CPP will be randomly allocated to intensive care unit beds of patients with closed head injury (CHI) or subarachnoid hemorrhage (SAH) in whom intracranial pressure monitors and arterial lines have been placed for medical management, stratified by primary diagnosis (CHI or SAH) and severity. Continuous data will be collected from 150 patients with and 150 patients without the interface monitor for the duration of CPP monitoring. The primary hypothesis being tested is that the Glasgow Outcome Score (GOS) 6 months after acute care discharge will be significantly better in those monitored with the continuous CPP display. Secondary endpoints are GOS at discharge and 3 months after discharge, Functional Independence Measure (FIM) score at discharge, and the Functional Status examination at 3 and 6 months. The percentage of CPP below set levels during hospital monitoring will be determined.
No CPP thresholds have been established that adequately predict how well children who survive a brain injury will do. Thus we will describe the association between various CPP thresholds and children's outcome up to one year after their brain injury. The target number of children to be enrolled is 65.
Studies suggest that the regularity or variability of physiologic measures, for example, heart rate, may give information about how well the system can respond to challenges. Changes in variability may be associated with disease. Describing physiologic variability may therefore be useful to identify critically ill individuals with brain injury who are less able to adapt to challenges and may be a greater risk for further brain injury and poorer outcome.
Measures of the value that individuals place on the various health states are used to calculate quality adjusted life years and assess the cost-effectiveness of treatments. While measures have been developed to assess how individuals value different outcomes, information regarding the value placed on outcomes following brain injury is lacking. We will use these measures to carry out interviews of both brain injury survivors and those who have not had a brain injury to add to the knowledge in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Bedside display of cerebral perfusion pressure informationHighly visible continually updating color coded bar computer display of cerebral perfusion pressure. |
| 2 | Placebo comparator | Other: Bedside display of cerebral perfusion pressure informationBedside computer display with a blank screen except for a message indicating that the program is running. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Traumatic brain injury or subarachnoid hemorrhage
- Age 16 years or older
- Admitted to intensive care unit
- Invasive intracranial pressure and arterial blood pressure monitoring
Key exclusion criteria (10 listed)
- Impending death
- Inclusion Criteria for second phase of study (determination of CPP threshold in children):
- Traumatic brain injury
- Age 15 years or younger
- Able to communicate by telephone
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 |
|---|---|---|
| Bedside display of cerebral perfusion pressure informationContinually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure | Other | 1, 2 |
Primary outcome
Glasgow Outcome Scale
Time frame: Six month follow-up
4 secondary outcomes
Glasgow Outcome Scale
Time frame: Hospital discharge and three month follow-up
Functional Status Examination
Time frame: Three and six-month follow-up
SF-36 Quality of Life
Time frame: Six month follow-up
Patient Competency Rating Scale
Time frame: Six month follow-up
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 2 Jun 2014.
- Background: PubMed 12168293Mitchell PH, Burr RL, Kirkness CJ. Information technology and CPP management in neuro intensive care. Acta Neurochir Suppl. 2002;81:163-5. doi: 10.1007/978-3-7091-6738-0_42.
- Results publication: PubMed 15068659Kirkness CJ, Burr RL, Mitchell PH, Newell DW. Is there a sex difference in the course following traumatic brain injury? Biol Res Nurs. 2004 Apr;5(4):299-310. doi: 10.1177/1099800404263050.
- Results publication: PubMed 12080869Kirkness CJ, Thompson JM, Ricker BA, Buzaitis A, Newell DW, Dikmen S, Mitchell PH. The impact of aneurysmal subarachnoid hemorrhage on functional outcome. J Neurosci Nurs. 2002 Jun;34(3):134-41. doi: 10.1097/01376517-200206000-00006.
- Results publication: PubMed 17053267Kirkness CJ, Burr RL, Cain KC, Newell DW, Mitchell PH. Effect of continuous display of cerebral perfusion pressure on outcomes in patients with traumatic brain injury. Am J Crit Care. 2006 Nov;15(6):600-9; quiz 610.
- Results publication: PubMed 16463811Kirkness CJ, Burr RL, Cain KC, Newell DW, Mitchell PH. Relationship of cerebral perfusion pressure levels to outcome in traumatic brain injury. Acta Neurochir Suppl. 2005;95:13-6. doi: 10.1007/3-211-32318-x_3.
- Results publication: PubMed 18066502Kirkness CJ, Burr RL, Thompson HJ, Mitchell PH. Temperature rhythm in aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2008;8(3):380-90. doi: 10.1007/s12028-007-9034-y.
- Results publication: PubMed 17223560Thompson HJ, Kirkness CJ, Mitchell PH. Intensive care unit management of fever following traumatic brain injury. Intensive Crit Care Nurs. 2007 Apr;23(2):91-6. doi: 10.1016/j.iccn.2006.11.005. Epub 2007 Jan 12.
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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.
Catherine J Kirkness, PhD principal investigator
University of Washington
Pamela H Mitchell, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside display of cerebral perfusion pressure information in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Washington 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 4 inclusion and 10 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 2 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Glasgow Outcome Scale (time frame: Six month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00194441, which also lists 7 linked publications.
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 2 Jun 2014.