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Impedance Threshold Device Tilt Study

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00137319
Enrollment
2
Registered
2005-08-29
Start date
2004-10-31
Completion date
2006-06-30
Last updated
2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension

Keywords

inspiratory impedance threshold device, blood pressure regulation, head-up tilt test, tilt table testing, burn injury, Burns

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.

Interventions

Sponsors

United States Army Institute of Surgical Research
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026