- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810419
Ultrasound Estimation of Spleen Size
Estimation of Spleen Size With Hand Held Ultrasound
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Coastal Health (VCHRI/VCHA)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients in the practices of hematologists at VGH (Vancouver General Hospital) who are expected to have normal size spleens as well as various degrees of splenomegaly
Exclusion Criteria:
- will exclude patients who cannot speak English or who cannot give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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:
|
Vscan Ultrasound used to determine spleen size and the other qualities described in the arm description.
Other Names:
Conventional Ultrasound used to determine spleen size and the other qualities described in the arm description.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
longitudinal measure of spleen in centimeters
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of spleen size
Time Frame: 1 day
|
Diagnosis
|
1 day
|
time to complete Vscan examination
Time Frame: 1 day
|
Time to complete Vscan exam
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality and best views
Time Frame: 1 day
|
Adequacy of study
Best Views obtained
|
1 day
|
Diagnostic Certainty
Time Frame: 1 day
|
Diagnostic Certainty
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-03055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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