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

Acute Hypotension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780350
• Other study ID #: W81XWH-BAA-11-1
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2012
• Last updated: February 12, 2015
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2015
• Source: Advanced Circulatory Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hypotension
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Circulatory Systems

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No