Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
This trial is active, not recruiting.
|Sponsor||Advanced Circulatory Systems|
|Start date||April 2012|
|End date||March 2013|
|Trial size||120 participants|
|Trial identifier||NCT01780350, W81XWH-BAA-11-1|
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
time frame: During device use, up to 1 hour
time frame: Duration of device use, up to 1 hour
Male or female participants at least 18 years old.
Inclusion Criteria: - adults between the ages of 18-120 years - presenting to EMS with or development of Hypotension during EMS interaction - treated by EMS with the ITD Exclusion Criteria: - pediatric patients - patients that do not present with or develop hypotension - patients who the ITD will not form a secure seal due to anatomical abnormalities
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