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Completed

NCT Number: NCT00256724

Efficacy Study of a Facemask Device to Treat Hypotension

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Dehydration Hemorrhage Hypovolemia Infections Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Vascular Diseases Water-Electrolyte Imbalance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impedance Threshold Device

Device

Active impedance threshold device

Other names: ResQGard

sham ITD

Device

sham impedance threshold device

Primary outcomes

  1. 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

Secondary outcomes

  1. Quantity of Fluid Administration

    Time frame: during 10 minutes of device use

Sponsors and collaborators

Lead sponsor

Advanced Circulatory Systems

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2005
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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