NCT00256724

Brief Summary

The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

July 18, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

November 18, 2005

Results QC Date

May 24, 2013

Last Update Submit

July 24, 2013

Conditions

Hypotension

Keywords

hypotensionhypovolemiadehydrationsepsisblood loss

Outcome Measures

Primary Outcomes (1)

  • Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline

    every 2 minutes during 10 minutes of device use

Secondary Outcomes (1)

  • Quantity of Fluid Administration

    during 10 minutes of device use

Study Arms (2)

Sham ITD

SHAM COMPARATOR

sham Impedance Threshold Device

Device: sham ITD

active ITD

ACTIVE COMPARATOR

active impedance threshold device

Device: Impedance Threshold Device

Interventions

Impedance Threshold DeviceDEVICE

Active impedance threshold device

Also known as: ResQGard
active ITD
sham ITDDEVICE

sham impedance threshold device

Sham ITD

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conscious patient
  • Systolic blood pressure \< 95 mmHg
  • Hypotension caused by blood loss, sepsis, or dehydration

You may not qualify if:

  • Hypotension secondary to heart failure
  • Complaints of chest pain
  • History of heart failure
  • Complaints of shortness of breath

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (4)

  • Convertino VA, Cooke WH, Lurie KG. Inspiratory resistance as a potential treatment for orthostatic intolerance and hemorrhagic shock. Aviat Space Environ Med. 2005 Apr;76(4):319-25.

    PMID: 15828629BACKGROUND

  • Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.

    PMID: 15864634BACKGROUND

  • Convertino VA, Ratliff DA, Ryan KL, Doerr DF, Ludwig DA, Muniz GW, Britton DL, Clah SD, Fernald KB, Ruiz AF, Lurie KG, Idris AH. Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers. Crit Care Med. 2004 Sep;32(9 Suppl):S381-6. doi: 10.1097/01.ccm.0000134348.69165.15.

    PMID: 15508665BACKGROUND

  • Smith SW, Parquette B, Lindstrom D, Metzger AK, Kopitzke J, Clinton J. An impedance threshold device increases blood pressure in hypotensive patients. J Emerg Med. 2011 Nov;41(5):549-58. doi: 10.1016/j.jemermed.2010.05.013. Epub 2010 Jul 15.

    PMID: 20634018RESULT

Related Links

MeSH Terms

Conditions

HypotensionHypovolemiaDehydrationSepsisHemorrhage

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammation

Results Point of Contact

Title
Nathan Burkhart
Organization
Advanced Circulatory
nburkhart@advancedcirculatory.com
651.403.5600

Study Officials

  • Keith Lurie, MD

    Advanced Circulatory Systems

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 31, 2013

Results First Posted

July 18, 2013

Record last verified: 2013-07

Locations

US(1)