Efficacy Study of a Facemask Device to Treat Hypotension

Overview

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 Title of Study: “Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2008

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.

Interventions

  • Device: Impedance Threshold Device
    • Active impedance threshold device
  • Device: sham ITD
    • sham impedance threshold device

Arms, Groups and Cohorts

  • Sham Comparator: Sham ITD
    • sham Impedance Threshold Device
  • Active Comparator: active ITD
    • active impedance threshold device

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Quantity of Fluid Administration
    • Time Frame: during 10 minutes of device use

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Advanced Circulatory Systems
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Keith Lurie, MD, Principal Investigator, Advanced Circulatory Systems

References

Convertino VA, Cooke WH, Lurie KG. Inspiratory resistance as a potential treatment for orthostatic intolerance and hemorrhagic shock. Aviat Space Environ Med. 2005 Apr;76(4):319-25.

Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.

Convertino VA, Ratliff DA, Ryan KL, Doerr DF, Ludwig DA, Muniz GW, Britton DL, Clah SD, Fernald KB, Ruiz AF, Lurie KG, Idris AH. Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers. Crit Care Med. 2004 Sep;32(9 Suppl):S381-6. doi: 10.1097/01.ccm.0000134348.69165.15.

Citations Reporting on Results

Smith SW, Parquette B, Lindstrom D, Metzger AK, Kopitzke J, Clinton J. An impedance threshold device increases blood pressure in hypotensive patients. J Emerg Med. 2011 Nov;41(5):549-58. doi: 10.1016/j.jemermed.2010.05.013. Epub 2010 Jul 15.

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