Efficacy Study of a Facemask Device to Treat Hypotension

• ClinicalTrials.gov Identifier: NCT00256724
• Recruitment Status: Completed
• First Posted: November 22, 2005
• Results First Posted: July 18, 2013
• Last Update Posted: July 31, 2013
• Sponsor: Advanced Circulatory Systems
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Advanced Circulatory Systems

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypotension	Device: Impedance Threshold Device; Device: sham ITD	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: June 2005
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline [ Time Frame: every 2 minutes during 10 minutes of device use ]

Secondary Outcome Measures :

1. Quantity of Fluid Administration [ Time Frame: during 10 minutes of device use ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

Advanced Circulatory Systems

United States Department of Defense

Investigators

• Principal Investigator: Keith Lurie, MD; Advanced Circulatory Systems

More Information

Additional Information:

Advanced Circulatory Systems, Inc. home page 

Publications of Results:

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.

Other Publications:

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
• Other Study ID Numbers: 43-0278-00; Contract W81XWH-04-C-0022
• First Posted: November 22, 2005
• Results First Posted: July 18, 2013
• Last Update Posted: July 31, 2013
• Last Verified: July 2013

Keywords provided by Advanced Circulatory Systems:

hypotension; hypovolemia; dehydration; sepsis; blood loss

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases