Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Blood pressure [ Time Frame: During device use, up to 1 hour ] [ Designated as safety issue: No ]Determining whether the application of an ITD will provide improvement in blood pressure in subjects with hypotension in patients being treated by San Antonio EMS.
- Tolerability [ Time Frame: Duration of device use, up to 1 hour ] [ Designated as safety issue: No ]Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: ResQGARD ITD
Subjects receive a ResQGARD ITD.
Device: ResQGARD ITD
Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.