Efficacy Study of a Facemask Device to Treat Hypotension

Phase 2

Completed

• Conditions: Hypotension
• Interventions: Device: sham ITD; Device: Impedance Threshold Device

• Registration Number: NCT00256724
• Lead Sponsor: Advanced Circulatory Systems

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 Description

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-22
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2013-05-24
• Results First Submitted QC: 2013-05-24
• Status Verified: 2013-07
• Results First Posted: 2013-07-18
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Conscious patient
• Systolic blood pressure < 95 mmHg
• Hypotension caused by blood loss, sepsis, or dehydration

Exclusion Criteria

• Hypotension secondary to heart failure
• Complaints of chest pain
• History of heart failure
• Complaints of shortness of breath

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham ITD	sham ITD	sham Impedance Threshold Device
active ITD	Impedance Threshold Device	active impedance threshold device

Primary Outcome Measures

Name	Time	Method
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline	every 2 minutes during 10 minutes of device use

Secondary Outcome Measures

Name	Time	Method
Quantity of Fluid Administration	during 10 minutes of device use

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States