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B40 Non-Invasive Blood Pressure Equivalency Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01546285
First received: February 28, 2012
Last updated: May 2, 2013
Last verified: May 2013
Results First Received: January 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Blood Pressure
Intervention: Device: Blood Pressure Readings on B40 Patient Monitor

  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
Healthy subjects were recruited from 03.07.2012 - 03.23.2012 from Clinimark LLC, an independent physiology lab.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subject distribution requirements (i.e. gender, blood pressure, and arm circumference)were reviewed as part of screening prior to subject enrollment.

Reporting Groups
  Description
Blood Pressure Reading Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings

Participant Flow:   Overall Study
    Blood Pressure Reading  
STARTED     66  
COMPLETED     66  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Blood Pressure Reading Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings

Baseline Measures
    Blood Pressure Reading  
Number of Participants  
[units: participants]
  66  
Age  
[units: participants]
 
<=18 years     17  
Between 18 and 65 years     45  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  32  ± 19.7  
Gender  
[units: participants]
 
Female     38  
Male     28  
Region of Enrollment  
[units: participants]
 
United States     66  
Systolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
  125.0  ± 25.3  
Diastolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
  73  ± 15.4  
Mean Arterial Pressure (MAP)  
[units: mmHg]
Mean ± Standard Deviation
  92.7  ± 17.2  



  Outcome Measures

1.  Primary:   Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements   [ Time Frame: End of each blood pressure reading ]


  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
None


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jeffrey Conner - Global Research Manager
Organization: GE Healthcare
phone: 414.721.2423
e-mail: Jeffrey.Conner@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01546285     History of Changes
Other Study ID Numbers: 118.04-2011-GES-0002
Study First Received: February 28, 2012
Results First Received: January 16, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board