search
Back to results

Impedance Threshold Device Tilt Study

Primary Purpose

Orthostatic Hypotension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impedance threshold device
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring inspiratory impedance threshold device, blood pressure regulation, head-up tilt test, tilt table testing, burn injury, Burns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • US Army Institute of Surgical Research

Outcomes

Primary Outcome Measures

Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
July 20, 2015
Sponsor
United States Army Institute of Surgical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00137319
Brief Title
Impedance Threshold Device Tilt Study
Official Title
An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Aims of the study re-evaluated, did not justify allocation of resources.
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
inspiratory impedance threshold device, blood pressure regulation, head-up tilt test, tilt table testing, burn injury, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Impedance threshold device
Primary Outcome Measure Information:
Title
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis Hedman, MPT, CPT, SP
Organizational Affiliation
US Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

Impedance Threshold Device Tilt Study

We'll reach out to this number within 24 hrs