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Impedance Threshold Device Tilt Study

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ClinicalTrials.gov Identifier: NCT00137319
Recruitment Status : Terminated (Aims of the study re-evaluated, did not justify allocation of resources.)
First Posted : August 29, 2005
Last Update Posted : July 22, 2015
Sponsor:
Information provided by:
United States Army Institute of Surgical Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Device: Impedance threshold device Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients
Study Start Date : October 2004
Actual Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension. [ Time Frame: 1 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137319


Locations
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United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
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Principal Investigator: Travis Hedman, MPT, CPT, SP US Army Institute of Surgical Research
More Information
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Publications:
Convertino VA, Idris A, Ratliff D, Ryan K, Doerr D, Lurie K. Use of an inspiratory impedance threshold valve increases cardiac output in human volunteers. Crit. Care Med. 30:A66, 2003

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ClinicalTrials.gov Identifier: NCT00137319    
Other Study ID Numbers: H-04-016
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by United States Army Institute of Surgical Research:
inspiratory impedance threshold device
blood pressure regulation
head-up tilt test
 tilt table testing
burn injury
Burns
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases