Status:
COMPLETED
Efficacy Study of a Facemask Device to Treat Hypotension
Lead Sponsor:
Advanced Circulatory Systems
Collaborating Sponsors:
United States Department of Defense
Conditions:
Hypotension
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 hypotensio...
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 ...
Eligibility Criteria
Inclusion
- Conscious patient
- Systolic blood pressure \< 95 mmHg
- Hypotension caused by blood loss, sepsis, or dehydration
Exclusion
- Hypotension secondary to heart failure
- Complaints of chest pain
- History of heart failure
- Complaints of shortness of breath
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00256724
Start Date
June 1 2005
End Date
January 1 2008
Last Update
July 31 2013
Active Locations (1)
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1
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404