Efficacy Study of a Facemask Device to Treat Hypotension

Advanced Circulatory Systems

Status and phase: Completed; Phase 2

Conditions: Hypotension

Treatments: Device: sham ITD; Device: Impedance Threshold Device

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00256724

43-0278-00

Contract W81XWH-04-C-0022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups

Sham ITD

Sham Comparator group

Description:

sham Impedance Threshold Device

Treatment:

Device: sham ITD

active ITD

Active Comparator group

Description:

active impedance threshold device

Treatment:

Device: Impedance Threshold Device