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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00571623
Collaborator
Neuroscience Nursing Foundation (Other)
40
3
6
13.3
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chest Physiotherapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1

All subjects act as their own contral

Other: Chest Physiotherapy
10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU

Outcome Measures

Primary Outcome Measures

  1. Intracranial pressure [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mission Hospital Mission Viejo California United States 92691
2 Duke University Durham North Carolina United States 27705
3 WakeMed Hospital Raleigh North Carolina United States 27610

Sponsors and Collaborators

  • Duke University
  • Neuroscience Nursing Foundation

Investigators

  • Principal Investigator: DaiWai M Olson, Phd RN CCRN, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00571623
Other Study ID Numbers:
  • Pro00001842
First Posted:
Dec 12, 2007
Last Update Posted:
Jul 9, 2014
Last Verified:
Aug 1, 2008
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2014