Automated Chest Physiotherapy to Improve Outcomes in Neuro (ACTION-ICP)

This study has been completed.
Sponsor:
Collaborator:
Neuroscience Nursing Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00571623
First received: December 10, 2007
Last updated: July 8, 2014
Last verified: August 2008
  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.

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Duke University
ClinicalTrials.gov Identifier: NCT00571623     History of Changes
Other Study ID Numbers: Pro00001842
Study First Received: December 10, 2007
Last Updated: July 8, 2014
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
Brain Injuries
Intracranial Hypertension
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 October 16, 2014