NCT00137319

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

First QC Date

August 25, 2005

Last Update Submit

July 20, 2015

Conditions

Orthostatic Hypotension

Keywords

inspiratory impedance threshold deviceblood pressure regulationhead-up tilt testtilt table testingburn injuryBurns

Outcome Measures

Primary Outcomes (1)

  • Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.

    1 hour

Interventions

Impedance threshold deviceDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related 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

    BACKGROUND

MeSH Terms

Conditions

Hypotension, OrthostaticBurns

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • Travis Hedman, MPT, CPT, SP

    US Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

October 1, 2004

Study Completion

June 1, 2006

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

US(1)