Impedance Threshold Device Tilt Study



Status:Terminated
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:October 2004
End Date:June 2006

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Trial Summary
Trial Overview
Inclusion Criteria

An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients

This study will see if a special piece of equipment can help burn patients who have been in
bed for a long time to get out of bed without feeling dizzy or faint.

To measure stroke volume, cardiac output, arterial blood pressure and cerebral blood flow
velocity in human patients while they undergo exposure to head-up tilt that is designed to
test their tolerance to an orthostatic challenge.

Inclusion Criteria:

- Military or civilian males or females between the ages of 18-65 years

- Burn injury with at least one unburned finger for Portapres measurement

- Minimum of 96 hours bedrest or physician directive to tilt

Exclusion Criteria:

- Age < 18 and > 65 years

- Facial burns when application of ITD device would cause further trauma

- Medical monitoring devices that preclude the use of the ITD

- Signs of cardiac abnormalities, autonomic dysfunction

- Chronic obstructive pulmonary disease (COPD), or any other respiratory limitations
(ventilator dependent, intubated, tracheostomy) limiting use of ITD

- History of pre-syncopal/syncopal episodes or orthostatic hypotension

- History of atherosclerotic coronary heart disease

- Patients taking any kind of cardiovascular pressor medications

- Inability to obtain a Portapres pulse wave validated by blood pressure cuff with +/-
5mmHg diastolic blood pressure

- Unable to provide informed consent for self
We found this trial at
1
site
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas 78234
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mi
from
Fort Sam Houston, TX
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