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 Overview

• Status: Completed
• Conditions: Acute Hypotension
• Intervention / Treatment: Device: ResQGARD ITD

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure From Baseline (Before ITD Use)	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.	During device use, up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	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.	Duration of device use, up to 1 hour

Collaborators and Investigators

• Sponsor: Advanced Circulatory Systems

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Estimate): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: W81XWH-BAA-11-1