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

Advanced Circulatory Systems

Status and phase: Completed; Phase 4

Conditions: Acute Hypotension

Treatments: Device: ResQGARD ITD

Study type: Interventional

Funder types: Industry

Identifiers

NCT01780350

W81XWH-BAA-11-1

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

ResQGARD ITD

Experimental group

Description:

Subjects receive a ResQGARD ITD.

Treatment:

Device: ResQGARD ITD