MedPath

Impedance Threshold Device Tilt Study

Not Applicable
Terminated
Conditions
Orthostatic Hypotension
Registration Number
NCT00137319
Lead Sponsor
United States Army Institute of Surgical Research
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 tolerance to an orthostatic challenge.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.1 hour
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

US Army Institute of Surgical Research

🇺🇸

Fort Sam Houston, Texas, United States

US Army Institute of Surgical Research
🇺🇸Fort Sam Houston, Texas, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.