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

July 8, 2014 updated by: Duke University

Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mission Viejo, California, United States, 92691
        • Mission Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 subjects with a neurological diagnosis and current ICP in situ.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracranial pressure
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Neuroscience Nursing Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001842

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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