Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

Phase 4

Completed

• Conditions: Acute Hypotension
• Interventions: Device: ResQGARD ITD

• Registration Number: NCT01780350
• Lead Sponsor: Advanced Circulatory Systems

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-19
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Status Verified: 2015-02
• Results First Submitted: 2015-02-12
• Results First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ResQGARD ITD	ResQGARD ITD	Subjects receive a ResQGARD ITD.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure From Baseline (Before ITD Use)	During device use, up to 1 hour	Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Tolerability	Duration of device use, up to 1 hour	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.