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
Results First Received: May 24, 2013  
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
Condition: Hypotension
Interventions: Device: Impedance Threshold Device
Device: sham ITD

  Participant Flow
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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
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Reporting Groups
  Description
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  
NOT COMPLETED     5     8  
Physician Decision                 2                 5  
Protocol Violation                 3                 3  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  23     24     47  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     20     20     40  
>=65 years     3     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  51.6  ± 11.8     46.8  ± 17.3     49.1  ± 15.0  
Gender  
[units: participants]
     
Female     13     15     28  
Male     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     23     24     47  



  Outcome Measures
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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
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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
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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
e-mail: nburkhart@advancedcirculatory.com


Publications of Results:
Other 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