Efficacy Study of a Facemask Device to Treat Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256724
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : July 18, 2013
Last Update Posted : July 31, 2013
United States Department of Defense
Information provided by (Responsible Party):
Advanced Circulatory Systems

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypotension
Interventions: Device: Impedance Threshold Device
Device: sham ITD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the emergency department based on age (18-85)and systolic blood pressure ≤95mmHg who were conscious and presumed to have hypotension due to hypoivolemia or relative hypovolemia (blood loss, dehydration, or sepsis).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Sham ITD sham Impedance Threshold Device
Active ITD active impedance threshold device

Participant Flow:   Overall Study
    Sham ITD   Active ITD
STARTED   23   24 
COMPLETED   18   16 
Physician Decision                2                5 
Protocol Violation                3                3 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Sham ITD sham Impedance Threshold Device
Active ITD active impedance threshold device
Total Total of all reporting groups

Baseline Measures
   Sham ITD   Active ITD   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   24   47 
[Units: Participants]
<=18 years   0   1   1 
Between 18 and 65 years   20   20   40 
>=65 years   3   3   6 
[Units: Years]
Mean (Standard Deviation)
 51.6  (11.8)   46.8  (17.3)   49.1  (15.0) 
[Units: Participants]
Female   13   15   28 
Male   10   9   19 
Region of Enrollment 
[Units: Participants]
United States   23   24   47 

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Quantity of Fluid Administration   [ Time Frame: during 10 minutes of device use ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Nathan Burkhart
Organization: Advanced Circulatory
phone: 651.403.5600

Publications of Results:
Other Publications:

Responsible Party: Advanced Circulatory Systems Identifier: NCT00256724     History of Changes
Other Study ID Numbers: 43-0278-00
Contract W81XWH-04-C-0022
First Submitted: November 18, 2005
First Posted: November 22, 2005
Results First Submitted: May 24, 2013
Results First Posted: July 18, 2013
Last Update Posted: July 31, 2013