Expired Study
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Fort Sam Houston, Texas 78234


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.


Study summary:

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.


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


Study is Available At:


Original ID:

H-04-016


NCT ID:

NCT00137319


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

United States Army Institute of Surgical Research


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Aims of the study re-evaluated, did not just


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Travis Hedman, MPT, CPT, SP
Principal Investigator
US Army Institute of Surgical Research

Study Dates

Start Date:October 2004
Completion Date:June 2006
Completion Type:Actual
Verification Date:July 2015
Last Changed Date:July 20, 2015
First Received Date:August 25, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
Time Frame:1 hour
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Impedance threshold device

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:United States Army Institute of Surgical Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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