Text Size

Impedance Threshold Device Tilt Study

This study has been terminated.
(Aims of the study re-evaluated, did not justify allocation of resources.)
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137319
First received: August 25, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention
Orthostatic Hypotension
 Device: Impedance threshold device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

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

Enrollment: 2
Study Start Date: October 2004
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137319

Locations
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
Principal Investigator: Travis Hedman, MPT, CPT, SP US Army Institute of Surgical Research
  More Information

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

ClinicalTrials.gov Identifier: NCT00137319     History of Changes
Other Study ID Numbers: H-04-016
Study First Received: August 25, 2005
Last Updated: July 24, 2008
Health Authority: United States: Federal Government

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:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013