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

NCT ID: NCT01780350

Last Updated: 2015-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Hypotension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ResQGARD ITD

Subjects receive a ResQGARD ITD.

Group Type EXPERIMENTAL

ResQGARD ITD

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Circulatory Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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W81XWH-BAA-11-1

Identifier Type: -

Identifier Source: org_study_id