Impedance Threshold Device Tilt Study | NCT00137319

Studies
Impedance Threshold Device Tilt Study

NCT00137319

Sponsor

United States Army Institute of Surgical Research

Status

Terminated

Last Update Posted

Jul 22, 2015Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Orthostatic Hypotension

Interventions

Impedance threshold device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Aims of the study re-evaluated, did not justify allocation of resources.

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Name	Type	Description	Arm Group Labels	Other Names
Impedance threshold device	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Travis Hedman, MPT, CPT, SP	US Army Institute of Surgical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
US Army Institute of Surgical Research		Fort Sam Houston	Texas	78234	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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

ID	Term
D007024	Hypotension, Orthostatic
D002056	Burns

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases