Impedance Threshold Device Tilt Study

United States Army Institute of Surgical Research2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Orthostatic Hypotension

Interventions

Impedance threshold deviceDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Outcomes

Primary Outcomes

Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.

Time frame: 1 hour

Data from ClinicalTrials.gov

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