Efficacy Study of a Facemask Device to Treat Hypotension

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT00256724
First received: November 18, 2005
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Hypotension
Device: Impedance Threshold Device
Device: sham ITD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension

Resource links provided by NLM:


Further study details as provided by Advanced Circulatory Systems:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantity of Fluid Administration [ Time Frame: during 10 minutes of device use ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham ITD
sham Impedance Threshold Device
Device: sham ITD
sham impedance threshold device
Active Comparator: active ITD
active impedance threshold device
Device: Impedance Threshold Device
Active impedance threshold device
Other Name: ResQGard

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256724

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Advanced Circulatory Systems
Investigators
Principal Investigator: Keith Lurie, MD Advanced Circulatory Systems
  More Information

Additional Information:
Publications:
Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT00256724     History of Changes
Other Study ID Numbers: 43-0278-00, Contract W81XWH-04-C-0022
Study First Received: November 18, 2005
Results First Received: May 24, 2013
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Circulatory Systems:
hypotension
hypovolemia
dehydration
sepsis
blood loss

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014