Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination

This study has been completed.
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Maria Yialamas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01948076
First received: September 16, 2013
Last updated: February 27, 2015
Last verified: February 2015
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Splenomegaly
Pleural Effusion
Intervention: Device: resident with GE vscan

  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
Beginning in Septemeber 2012 all internal medicine residents at Brigham and Women's hospital were invited to participate and the first 40 residents to respond to email advertisement were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Residents with formal ultrasound training were to be excluded but none of the potential participants had had formal training.

Reporting Groups
  Description
Control Group Performed only physical exam with no access to ultrasoun
Intervention Group Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam

Participant Flow:   Overall Study
    Control Group     Intervention Group  
STARTED     20     20  
COMPLETED     20     19  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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
Resident Without GE Vscan baseline physical exam use
Resident With GE Vscan residents with augmentation of physical exam by ultrasound
Total Total of all reporting groups

Baseline Measures
    Resident Without GE Vscan     Resident With GE Vscan     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  29.3  (2.3)     29.5  (1.9)     29.4  (2.1)  
Gender  
[units: participants]
     
Female     8     10     18  
Male     12     10     22  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam   [ Time Frame: one month ]

2.  Secondary:   Improvement in Diagnostic Ability Within the Intervention Group   [ Time Frame: one month ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maria Yialamas
Organization: Brigham and Women's Hospital
phone: 617-732-5500
e-mail: myialamas@partners.org


No publications provided by Brigham and Women's Hospital

Publications automatically indexed to this study:

Responsible Party: Maria Yialamas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01948076     History of Changes
Other Study ID Numbers: 2011P-002845
Study First Received: September 16, 2013
Results First Received: October 22, 2013
Last Updated: February 27, 2015
Health Authority: United States: Institutional Review Board