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

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: NCT01948076
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : February 26, 2015
Last Update Posted : March 19, 2015
General Electric
Information provided by (Responsible Party):
Maria Yialamas, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Splenomegaly
Pleural Effusion
Intervention: Device: resident with GE vscan

  Participant Flow

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
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 
Withdrawal by Subject                0                1 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 29.3  (2.3)   29.5  (1.9)   29.4  (2.1) 
[Units: Participants]
Female   8   10   18 
Male   12   10   22 
Region of Enrollment 
[Units: Participants]
United States   20   20   40 

  Outcome Measures

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

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
No text entered.

  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Maria Yialamas, Brigham and Women's Hospital Identifier: NCT01948076     History of Changes
Other Study ID Numbers: 2011P-002845
First Submitted: September 16, 2013
First Posted: September 23, 2013
Results First Submitted: October 22, 2013
Results First Posted: February 26, 2015
Last Update Posted: March 19, 2015