Efficacy Study of a Facemask Device to Treat Hypotension

Status:	Archived
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension

The purpose of this study is to determine if the impedance threshold device (ITD) attached
to a facemask can increase blood pressure in patients who present to the emergency
department with hypotension secondary to hypovolemia. The cause of hypovolemia could be
blood loss, sepsis, or dehydration.

The study is designed to test the hypothesis that use of the ITD will result in a rapid rise
in blood pressure secondary to an increase in cardiac output. Either and active or sham ITD
will be applied to hypotensive patients when initially presented to the emergency department
with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise
in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well
as clinical studies performed to date, we hypothesize that use of the active ITD will result
in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical
parameters will also be compared between the two groups of patients.

We found this trial at

sites

University of Minnesota - Regions Hospital

St. Paul, Minnesota 55101

from

St. Paul, MN