Efficacy Study of a Facemask Device to Treat Hypotension

This study has been completed.

Sponsor:

Collaborator:

Department of Defense

Information provided by (Responsible Party):

Advanced Circulatory Systems

ClinicalTrials.gov Identifier:

NCT00256724

First received: November 18, 2005

Last updated: March 1, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hypotension	Device: Impedance Threshold Device Device: sham ITD	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension

Resource links provided by NLM:

MedlinePlus related topics: Dehydration Low Blood Pressure Sepsis

U.S. FDA Resources

Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:

Rise in systolic blood pressure over the first 10 minutes of use [ Time Frame: during 10 minutes of device use ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantity of fluid administration [ Time Frame: during 10 minutes of device use ] [ Designated as safety issue: No ]

Enrollment:	34
Study Start Date:	June 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Sham ITD sham Impedance Threshold Device	Device: sham ITD sham impedance threshold device
Active Comparator: active ITD active impedance threshold device	Device: Impedance Threshold Device Active impedance threshold device Other Name: ResQGard

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256724

Locations

United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

Advanced Circulatory Systems

Department of Defense

Investigators

Principal Investigator:

Keith Lurie, MD

Advanced Circulatory Systems

More Information

Additional Information:

Advanced Circulatory Systems, Inc. home page This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2010 Jul 15.

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. Review.

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. Epub 2005 Apr 28.

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.

Responsible Party:	Advanced Circulatory Systems
ClinicalTrials.gov Identifier:	NCT00256724 History of Changes
Other Study ID Numbers:	43-0278-00, Contract W81XWH-04-C-0022
Study First Received:	November 18, 2005
Last Updated:	March 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Advanced Circulatory Systems:

hypotension
hypovolemia
dehydration
sepsis
blood loss

Additional relevant MeSH terms:

Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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