Ultrasound Estimation of Spleen Size
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|ClinicalTrials.gov Identifier: NCT01810419|
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Splenomegaly||Device: Vscan Ultrasound (GE Healthcare, USA) Device: Conventional Ultrasound||Not Applicable|
The diagnosis of splenomegaly (abnormal enlargement of the spleen) is extremely important in managing patients with many medical conditions. The ability to recognize an enlarged spleen in a timely manner can impact patient outcomes. Although the physical exam can be used to confidently diagnosis massive enlargement of the spleen, evaluating lesser degrees of splenomegaly at the bedside proves more difficult. In current practice, the gold standard for diagnosis of splenomegaly is the standard abdominal ultrasound. The prevalence of splenomegaly in patients with several medical conditions such as blood disorders and cirrhosis is relatively high. Therefore, the demand for abdominal ultrasound is evergrowing and similarly the cost of caring for patients with these diseases increases.
Examination of the spleen is one of the core competencies that we expect our students and residents to learn as part of their training. This physical diagnosis manoeuver is frequently used to examine residents at the Royal College level and determine their fitness to practice. Unfortunately, the sensitivity and specificity of examination of the spleen at the bedside is not very good.
With the introduction of handheld ultrasound (HCU) devices, rapid bedside assessment of a patient is now possible. The Pocket-sized Vscan Ultrasound device (Vscan) (GE Healthcare, USA) allows for 2D imaging on a 3.5 inch display and has been shown to have comparable image quality to standard ultrasound for some applications. The Vscan and other HCU devices have been used at point of care to evaluate a number of conditions and can greatly impact treatment decisions in medical patients at the bedside. The ability to recognize splenomegaly in a timely manner can impact patient outcomes. In addition, the use of this technology could significantly impact training standards for students and residents.
It remains unclear whether bedside evaluation with the Vscan is able to accurately measure spleen size. Our study aims to determine the diagnostic accuracy of the Vscan when used by trained ultrasonographers, in patients with varying degrees of splenomegaly. If we can reliably show that a trained ultrasonographer can accurately characterize spleen size at the bedside with a handheld device, the next stage of the study will involve training medical residents in the use of handheld ultrasound to see if they can also reliably assess spleen size.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Estimation of Spleen Size With Hand Held Ultrasound|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||March 2014|
Experimental: normal and various degrees splenomegaly
Vscan Ultrasound (GE Healthcare, USA) Conventional Ultrasound (Ultrasonix) used to determine spleen size Crossover design, all subjects will be measured with both devices. half will have the handheld done first, then conventional half the Conventional done first, then handheld
Will complete questionaire for both:
Device: Vscan Ultrasound (GE Healthcare, USA)
Vscan Ultrasound used to determine spleen size and the other qualities described in the arm description.
Other Name: handheld ultrasound (HCU)
Device: Conventional Ultrasound
Conventional Ultrasound used to determine spleen size and the other qualities described in the arm description.
- longitudinal measure of spleen in centimeters [ Time Frame: 1 day ]
- Diagnosis of spleen size [ Time Frame: 1 day ]
- No Splenic Enlargement
- Moderate Splenic Enlargement
- Massive Splenic enlargement
- time to complete Vscan examination [ Time Frame: 1 day ]
Time to complete Vscan exam
- 5-10 min
- Image quality and best views [ Time Frame: 1 day ]
Adequacy of study
- Image quality inadequate to make diagnosis
- Image quality adequate
- Image quality excellent
Best Views obtained
- Right Lateral Decubitus
- Diagnostic Certainty [ Time Frame: 1 day ]
- Not confident
- Somewhat confident
- Very confident
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810419
|Canada, British Columbia|
|Vancouver Coastal Health (VCHRI/VCHA)|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Graydon S Meneilly, MD||University of British Columbia|