Efficacy Study of a Facemask Device to Treat Hypotension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypotension

In brief

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.

Key facts

Study ID

NCT00256724

Run by

Advanced Circulatory Systems

People needed

47

Starts

2005-06-01

Expected to finish

2008-01-01

Last updated by the study team

2013-07-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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