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Automated Chest Physiotherapy to Improve Outcomes in Neuro — ACTION-ICP  

Brain Injury Clinical Trial

Official title:
Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study

Clinical Trial Summary

Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.

Clinical Trial Description

The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.

1. The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.

2. The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study.

3. ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject. ;

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00571623
Study type Observational
Source Duke University
Contact
Status Completed
Phase N/A
Start date September 2007
Completion date March 2008
View Details
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