Efficacy Study of a Facemask Device to Treat Hypotension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypotension

Intervention / Treatment
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* Device: Impedance Threshold Device
* Device: sham ITD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham ITD<br>sham Impedance Threshold Device | Device: sham ITD<br>* sham impedance threshold device<br>|
| Active Comparator: active ITD<br>active impedance threshold device | Device: Impedance Threshold Device<br>* Active impedance threshold device<br>* Other names: ResQGard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of Fluid Administration |  | during 10 minutes of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypotension, hypovolemia, dehydration, sepsis, blood loss