Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Catherine Kirkness, University of Washington
ClinicalTrials.gov Identifier:
NCT00194441
First received: September 12, 2005
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Subarachnoid Hemorrhage
Other: Bedside display of cerebral perfusion pressure information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPP Management Information Feedback and Nursing

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Glasgow Outcome Scale [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glasgow Outcome Scale [ Time Frame: Hospital discharge and three month follow-up ] [ Designated as safety issue: No ]
  • Functional Status Examination [ Time Frame: Three and six-month follow-up ] [ Designated as safety issue: No ]
  • SF-36 Quality of Life [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
  • Patient Competency Rating Scale [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: April 1999
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Highly visible continually updating color coded bar computer display of cerebral perfusion pressure.
Other: Bedside display of cerebral perfusion pressure information
Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
Placebo Comparator: 2
Bedside computer display with a blank screen except for a message indicating that the program is running.
Other: Bedside display of cerebral perfusion pressure information
Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194441

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Catherine J Kirkness, PhD University of Washington
Principal Investigator: Pamela H Mitchell, PhD University of Washington
  More Information

Publications:
Responsible Party: Catherine Kirkness, Research Associate Professor,, University of Washington
ClinicalTrials.gov Identifier: NCT00194441     History of Changes
Other Study ID Numbers: 14622-C, 5R01NR004901-07
Study First Received: September 12, 2005
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
cerebral circulation
monitoring, physiologic
informatics
nursing care
physiologic variability
outcome
quality adjusted life years

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Injuries
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014