Impedance Threshold Device Tilt Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Orthostatic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Impedance threshold device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No