Automated Chest Physiotherapy to Improve Outcomes in Neuro

Completed

• Conditions: Intracranial Hypertension; Brain Injury
• Interventions: Other: Chest Physiotherapy

• Registration Number: NCT00571623
• Lead Sponsor: Duke University

Brief 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.

Detailed 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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-08
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed

Exclusion Criteria

• spinal cord injury such that CPT is not desired

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Chest Physiotherapy	All subjects act as their own contral

Primary Outcome Measures

Name	Time	Method
Intracranial pressure	1 hour

Trial Locations

Locations (3)

Mission Hospital; 🇺🇸 Mission Viejo, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

WakeMed Hospital; 🇺🇸 Raleigh, North Carolina, United States