Automated Chest Physiotherapy to Improve Outcomes in Neuro - Full Text View

Sponsors and Collaborators:	Duke University Neuroscience Nursing Foundation
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00571623

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

MedlinePlus related topics: High Blood Pressure Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study

Further study details as provided by Duke University:

Primary Outcome Measures:

Intracranial pressure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:

Elf K, Nilsson P, Enblad P. Outcome after traumatic brain injury improved by an organized secondary insult program and standardized neurointensive care. Crit Care Med. 2002 Sep;30(9):2129-34.

Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. Review.

Olson DM, Thoyre SM, Turner DA, Bennett S, Graffagnino C. Changes in intracranial pressure associated with chest physiotherapy. Neurocrit Care. 2007;6(2):100-3.

Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. Review.

Bader MK, Palmer S. Keeping the brain in the zone. Applying the severe head injury guidelines to practice. Crit Care Nurs Clin North Am. 2000 Dec;12(4):413-27. Review.

Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. Review.

Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. Review. No abstract available.

Responsible Party:	Duke University ( DaiWai Olson, Research Associate )
Study ID Numbers:	pRO00001842
Study First Received:	December 10, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00571623
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Brain Injury
Intracranial hypertension
Human subjects
Nursing care

Study placed in the following topic categories:

Craniocerebral Trauma
Pseudotumor cerebri
Wounds and Injuries
Vascular Diseases
Pseudotumor Cerebri
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009