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Efficacy Study of a Facemask Device to Treat Hypotension

NCT ID: NCT00256724

Last Updated: 2013-07-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of \<95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sham ITD

sham Impedance Threshold Device

Group Type SHAM_COMPARATOR

sham ITD

Intervention Type DEVICE

sham impedance threshold device

active ITD

active impedance threshold device

Group Type ACTIVE_COMPARATOR

Impedance Threshold Device

Intervention Type DEVICE

Active impedance threshold device

Interventions

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Impedance Threshold Device

Active impedance threshold device

Intervention Type DEVICE

sham ITD

sham impedance threshold device

Intervention Type DEVICE

Other Intervention Names

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ResQGard

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Hypotension secondary to heart failure
* Complaints of chest pain
* History of heart failure
* Complaints of shortness of breath
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Advanced Circulatory Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Lurie, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Circulatory Systems

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15828629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15864634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15508665 (View on PubMed)

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.

Reference Type RESULT
PMID: 20634018 (View on PubMed)

Related Links

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http://www.advancedcirculatory.com

Advanced Circulatory Systems, Inc. home page

Other Identifiers

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Contract W81XWH-04-C-0022

Identifier Type: -

Identifier Source: secondary_id

43-0278-00

Identifier Type: -

Identifier Source: org_study_id

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