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

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Duke University

Status

Completed

Conditions

Brain Injury
Intracranial Hypertension

Treatments

Other: Chest Physiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT00571623
Pro00001842

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

1
Description:
All subjects act as their own contral
Treatment:
Other: Chest Physiotherapy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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