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NCT00256724 Clinical Trial

Efficacy Study of a Facemask Device to Treat Hypotension

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256724
Other study ID # 43-0278-00
Secondary ID Contract W81XWH-
Status Completed
Phase Phase 2
First received November 18, 2005
Last updated July 24, 2013
Start date June 2005
Est. completion date January 2008

Study information
Verified date July 2013
Source Advanced Circulatory Systems
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Hennepin County Medical Center Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Advanced Circulatory Systems United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. Epub 2005 Apr 28. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline every 2 minutes during 10 minutes of device use No
Secondary Quantity of Fluid Administration during 10 minutes of device use No
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