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Efficacy Study of a Facemask Device to Treat Hypotension

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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:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Advanced Circulatory Systems

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 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
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256724


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

Additional Information:
Publications:
Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT00256724     History of Changes
Other Study ID Numbers: 43-0278-00
Contract W81XWH-04-C-0022
First Posted: November 22, 2005    Key Record Dates
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