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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
Sponsor:
Information provided by (Responsible Party):

March 7, 2013
March 13, 2013
April 14, 2017
March 2013
October 2013   (Final data collection date for primary outcome measure)
longitudinal measure of spleen in centimeters [ Time Frame: 1 day ]
Same as current
Complete list of historical versions of study NCT01810419 on ClinicalTrials.gov Archive Site
  • Diagnosis of spleen size [ Time Frame: 1 day ]

    Diagnosis

    1. No Splenic Enlargement
    2. Moderate Splenic Enlargement
    3. Massive Splenic enlargement
  • time to complete Vscan examination [ Time Frame: 1 day ]

    Time to complete Vscan exam

    1. <5min
    2. 5-10 min
    3. 10-15min
    4. >15min
Same as current
  • Image quality and best views [ Time Frame: 1 day ]

    Adequacy of study

    1. Image quality inadequate to make diagnosis
    2. Image quality adequate
    3. Image quality excellent

    Best Views obtained

    1. Supine
    2. Right Lateral Decubitus
  • Diagnostic Certainty [ Time Frame: 1 day ]

    Diagnostic Certainty

    1. Not confident
    2. Somewhat confident
    3. Very confident
Same as current
 
Ultrasound Estimation of Spleen Size
Estimation of Spleen Size With Hand Held Ultrasound
In internal medicine, assessment of spleen size on physical examination is an extremely important part of the overall evaluation of patients with many illnesses. Examination of the spleen is also one of the core competencies that the investigators expect our students and residents to learn as part of their training. Unfortunately, the sensitivity and specificity of examination of the spleen at the bedside is not very good. The investigators wish to determine if handheld ultrasound can accurately assess spleen size. Doing so would make physical examination of the spleen obsolete and transform training objectives for medical students and residents.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Splenomegaly
  • 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.
    Other Names:
    • Gold standard
    • standard ultrasound
    • Ultrasonix
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:

  1. Adequacy of image quality
  2. What is best view obtained
  3. Greatest Longitudinal Measure
  4. Diagnosis
  5. Diagnostic Certainty
  6. Time to Complete exam
Interventions:
  • Device: Vscan Ultrasound (GE Healthcare, USA)
  • Device: Conventional Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2014
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01810419
H12-03055
Yes
Not Provided
Plan to Share IPD: No
Graydon Meneilly, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Graydon S Meneilly, MD University of British Columbia
University of British Columbia
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP