Clinical trial NCT00571623: Automated Chest Physiotherapy to Improve Outcomes in Neuro
Official title: Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Intracranial Hypertension
Keywords: Brain Injury
Intracranial hypertension
Human subjects
Nursing care
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Neuroscience Nursing Foundation
First posted: 2007-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 subjects with a neurological diagnosis and current ICP in situ.

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.

Eligibility 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

Primary outcomes:
measure: Intracranial pressure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: DaiWai M Olson, Phd RN CCRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/00003246-200209000-00029.
citation: Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. doi: 10.1016/j.ccell.2004.03.005.
citation: 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. doi: 10.1007/s12028-007-0015-y.
citation: Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. doi: 10.1097/00044067-200510000-00007.
citation: 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.
citation: Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. doi: 10.1097/00044067-200510000-00003.
citation: Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. No abstract available.