Phase 4
Completed N=200
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
Acute Hypotension
Source: ClinicalTrials.gov NCT01780350 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Change in Systolic Blood Pressure From Baseline (Before ITD Use) — 17.9 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure From Baseline (Before ITD Use) |
17.9 | — |
| SECONDARY Tolerability |
115; 36; 30; 19 | — |
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
Data sourced from ClinicalTrials.gov (NCT01780350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.