Automated Chest Physiotherapy to Improve Outcomes in Neuro

NCT ID: NCT00571623

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Brain Injury Intracranial Hypertension

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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1

All subjects act as their own contral

Chest Physiotherapy

Intervention Type OTHER

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

Interventions

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Chest Physiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuroscience Nursing Foundation

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DaiWai M Olson, Phd RN CCRN

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Mission Hospital

Mission Viejo, California, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

WakeMed Hospital

Raleigh, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12352052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15358383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17522792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16269895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11855245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16269891 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9677936 (View on PubMed)

Other Identifiers

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Pro00001842

Identifier Type: -

Identifier Source: org_study_id

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