Automated Chest Physiotherapy to Improve Outcomes in Neuro (ACTION-ICP)
This study has been completed.
Sponsor:
Duke University
Collaborator:
Neuroscience Nursing Foundation
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00571623
First received: December 10, 2007
Last updated: August 13, 2008
Last verified: August 2008
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Purpose
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 | Intervention |
|---|---|
|
Brain Injury Intracranial Hypertension |
Other: Chest Physiotherapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Intracranial pressure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
- 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.
- 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.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
40 subjects with a neurological diagnosis and current ICP in situ.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571623
Locations
| United States, California | |
| Mission Hospital | |
| Mission Viejo, California, United States, 92691 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27705 | |
| 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 |
More Information
Publications:
| Responsible Party: | DaiWai Olson, Research Associate, Duke University |
| ClinicalTrials.gov Identifier: | NCT00571623 History of Changes |
| Other Study ID Numbers: | pRO00001842 |
| Study First Received: | December 10, 2007 |
| Last Updated: | August 13, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Brain Injury Intracranial hypertension Human subjects Nursing care |
Additional relevant MeSH terms:
|
Hypertension Intracranial Hypertension Brain Injuries Vascular Diseases Cardiovascular Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013