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

NCT01780350 | Completed Phase 4 Results

• 1 other identifier: W81XWH-BAA-11-1
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability

  Duration of device use, up to 1 hour

Study Arms (1)

ResQGARD ITD

EXPERIMENTAL

Subjects receive a ResQGARD ITD.

Device: ResQGARD ITD

Interventions

ResQGARD ITD DEVICE

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.

ResQGARD ITD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Circulatory Systems: lead

Results Point of Contact

• Title: David Wampler, PhD
• Organization: University of Texas Health Science Center San Antonio

wamplerd@uthscsa.edu

210.567.7598

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: January 31, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02