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Efficacy Study of a Facemask Device to Treat Hypotension

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT00256724
First received: November 18, 2005
Last updated: March 1, 2012
Last verified: March 2012
History of Changes

November 18, 2005
March 1, 2012
June 2005
January 2008   (final data collection date for primary outcome measure)
Rise in systolic blood pressure over the first 10 minutes of use [ Time Frame: during 10 minutes of device use ] [ Designated as safety issue: No ]
Rise in blood pressure over the first 10 minutes of use
Complete list of historical versions of study NCT00256724 on ClinicalTrials.gov Archive Site
Quantity of fluid administration [ Time Frame: during 10 minutes of device use ] [ Designated as safety issue: No ]
Quantity of fluid administration
Not Provided
Not Provided
 
Efficacy Study of a Facemask Device to Treat Hypotension
Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of 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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypotension
  • Device: Impedance Threshold Device
    Active impedance threshold device
    Other Name: ResQGard
  • Device: sham ITD
    sham impedance threshold device
  • Sham Comparator: Sham ITD
    sham Impedance Threshold Device
    Intervention: Device: sham ITD
  • Active Comparator: active ITD
    active impedance threshold device
    Intervention: Device: Impedance Threshold Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00256724
43-0278-00, Contract W81XWH-04-C-0022
No
Advanced Circulatory Systems
Advanced Circulatory Systems
Department of Defense
Principal Investigator: Keith Lurie, MD Advanced Circulatory Systems
Advanced Circulatory Systems
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP