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OpenTrials
Completed

NCT Number: NCT01780350

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

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.

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Key information

Conditions

Acute Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Systolic Blood Pressure From Baseline (Before ITD Use)

    Time frame: During device use, up to 1 hour

    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 outcomes

  1. Tolerability

    Time frame: Duration of device use, up to 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Advanced Circulatory Systems

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2013
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.