Impedance Threshold Device Tilt Study

Orthostatic Hypotension Clinical Trial

Official title:

An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137319
• Other study ID #: H-04-016
• Status: Terminated
• Phase: N/A
• First received: August 25, 2005
• Last updated: July 20, 2015
• Start date: October 2004
• Est. completion date: June 2006

Study information

• Verified date: July 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Device:
• Impedance threshold device

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.		1 hour