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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT01780350
First received: July 19, 2012
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Hypotension
 Device: ResQGARD ITD
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: During device use, up to 1 hour ] [ Designated as safety issue: No ]
    Determining whether the application of an ITD will provide improvement in blood pressure in subjects with hypotension in patients being treated by San Antonio EMS.


Secondary Outcome Measures:
  • Tolerability [ Time Frame: Duration of device use, up to 1 hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01780350     History of Changes
Other Study ID Numbers: W81XWH-BAA-11-1
Study First Received: July 19, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013