CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 enrolled
Drug / intervention
Bedside display of cerebral perfusion pressure informationother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194441
NCT00194441N/ACompleted

CPP Management Information Feedback and Nursing

University of Washington·interventional·Posted Sep 19, 2005·Updated Jun 2, 2014

In Brief

A clinical study evaluating Bedside display of cerebral perfusion pressure information for Traumatic Brain Injury and Subarachnoid Hemorrhage. Completed, enrolled 260 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartApr 1, 1999
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 20.8 years ago

Interventions

Bedside display of cerebral perfusion pressure informationother

Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure