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Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing

Primary Purpose

Traumatic Brain Injury, Subarachnoid Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bedside display of cerebral perfusion pressure information
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring cerebral circulation, monitoring, physiologic, informatics, nursing care, physiologic variability, outcome, quality adjusted life years

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Traumatic brain injury or subarachnoid hemorrhage Age 16 years or older Admitted to intensive care unit Invasive intracranial pressure and arterial blood pressure monitoring Exclusion Criteria: 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 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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Highly visible continually updating color coded bar computer display of cerebral perfusion pressure.

Bedside computer display with a blank screen except for a message indicating that the program is running.

Outcomes

Primary Outcome Measures

Glasgow Outcome Scale

Secondary Outcome Measures

Glasgow Outcome Scale
Functional Status Examination
SF-36 Quality of Life
Patient Competency Rating Scale

Full Information

First Posted
September 12, 2005
Last Updated
May 29, 2014
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00194441
Brief Title
Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing
Official Title
CPP Management Information Feedback and Nursing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Subarachnoid Hemorrhage
Keywords
cerebral circulation, monitoring, physiologic, informatics, nursing care, physiologic variability, outcome, quality adjusted life years

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Highly visible continually updating color coded bar computer display of cerebral perfusion pressure.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Bedside computer display with a blank screen except for a message indicating that the program is running.
Intervention Type
Other
Intervention Name(s)
Bedside display of cerebral perfusion pressure information
Intervention Description
Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale
Time Frame
Six month follow-up
Secondary Outcome Measure Information:
Title
Glasgow Outcome Scale
Time Frame
Hospital discharge and three month follow-up
Title
Functional Status Examination
Time Frame
Three and six-month follow-up
Title
SF-36 Quality of Life
Time Frame
Six month follow-up
Title
Patient Competency Rating Scale
Time Frame
Six month follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic brain injury or subarachnoid hemorrhage Age 16 years or older Admitted to intensive care unit Invasive intracranial pressure and arterial blood pressure monitoring Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine J Kirkness, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela H Mitchell, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12168293
Citation
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.
Results Reference
background
PubMed Identifier
15068659
Citation
Kirkness 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 Reference
result
PubMed Identifier
12080869
Citation
Kirkness 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 Reference
result
PubMed Identifier
17053267
Citation
Kirkness 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 Reference
result
PubMed Identifier
16463811
Citation
Kirkness 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 Reference
result
PubMed Identifier
18066502
Citation
Kirkness 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 Reference
result
PubMed Identifier
17223560
Citation
Thompson 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.
Results Reference
result

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Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing

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