Clinical Trial: Efficacy Study of a Facemask Device to Treat Hypotension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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 an 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.
Sponsor: Advanced Circulatory Systems

Current Primary Outcome: Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline [ Time Frame: every 2 minutes during 10 minutes of device use ]

Original Primary Outcome: Rise in blood pressure over the first 10 minutes of use

Current Secondary Outcome: Quantity of Fluid Administration [ Time Frame: during 10 minutes of device use ]

Original Secondary Outcome: Quantity of Fluid Administration

Information By: Advanced Circulatory Systems

Dates:
Date Received: November 18, 2005
Date Started: June 2005
Date Completion:
Last Updated: July 24, 2013
Last Verified: July 2013