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

Primary Purpose

Acute Hypotension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ResQGARD ITD
Sponsored by
Advanced Circulatory Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ResQGARD ITD

    Arm Description

    Subjects receive a ResQGARD ITD.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 19, 2012
    Last Updated
    February 12, 2015
    Sponsor
    Advanced Circulatory Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01780350
    Brief Title
    Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advanced Circulatory Systems

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ResQGARD ITD
    Arm Type
    Experimental
    Arm Description
    Subjects receive a ResQGARD ITD.
    Intervention Type
    Device
    Intervention Name(s)
    ResQGARD ITD
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Systolic Blood Pressure From Baseline (Before ITD Use)
    Description
    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.
    Time Frame
    During device use, up to 1 hour
    Secondary Outcome Measure Information:
    Title
    Tolerability
    Description
    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.
    Time Frame
    Duration of device use, up to 1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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