Impedance Threshold Device Tilt Study

United States Army Institute of Surgical Research

Status

Terminated

Conditions

Orthostatic Hypotension

Treatments

Device: Impedance threshold device

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00137319

H-04-016

Details and patient eligibility

About

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.

Full 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 tolerance to an orthostatic challenge.

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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