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Efficacy Study of a Facemask Device to Treat Hypotension

This study has been completed.
United States Department of Defense
Information provided by (Responsible Party):
Advanced Circulatory Systems Identifier:
First received: November 18, 2005
Last updated: July 24, 2013
Last verified: July 2013
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
Device: Impedance Threshold Device
Device: sham ITD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:
  • 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:
  • Quantity of Fluid Administration [ Time Frame: during 10 minutes of device use ]

Enrollment: 47
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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00256724

United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Advanced Circulatory Systems
United States Department of Defense
Principal Investigator: Keith Lurie, MD Advanced Circulatory Systems
  More Information

Additional Information:
Responsible Party: Advanced Circulatory Systems Identifier: NCT00256724     History of Changes
Other Study ID Numbers: 43-0278-00
Contract W81XWH-04-C-0022
Study First Received: November 18, 2005
Results First Received: May 24, 2013
Last Updated: July 24, 2013

Keywords provided by Advanced Circulatory Systems:
blood loss

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on May 22, 2017