Status:
TERMINATED
Impedance Threshold Device Tilt Study
Lead Sponsor:
United States Army Institute of Surgical Research
Conditions:
Orthostatic Hypotension
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 toleranc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00137319
Start Date
October 1 2004
End Date
June 1 2006
Last Update
July 22 2015
Active Locations (1)
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1
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234