Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00194441
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Catherine Kirkness, University of Washington

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE April 1999
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
Glasgow Outcome Scale [ Time Frame: Six month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Glasgow Outcome Scale at 6 month follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Glasgow Outcome Scale at discharge and 3 month follow-up, Functional Independence Measure at discharge, 3, and 6 month follow-up
  • SF-36 Quality of Life at 6 month follow-up
  • Patient Competency Rating Scale at 6 month follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cerebral Perfusion Pressure (CPP) Management Information Feedback and Nursing
Official Title  ICMJE CPP Management Information Feedback and Nursing
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage
Intervention  ICMJE Other: Bedside display of cerebral perfusion pressure information
Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
Study Arms  ICMJE
  • Experimental: 1
    Highly visible continually updating color coded bar computer display of cerebral perfusion pressure.
    Intervention: Other: Bedside display of cerebral perfusion pressure information
  • Placebo Comparator: 2
    Bedside computer display with a blank screen except for a message indicating that the program is running.
    Intervention: Other: Bedside display of cerebral perfusion pressure information
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
260
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
300
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194441
Other Study ID Numbers  ICMJE 14622-C
5R01NR004901-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catherine Kirkness, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Catherine J Kirkness, PhD University of Washington
Principal Investigator: Pamela H Mitchell, PhD University of Washington
PRS Account University of Washington
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP