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Completed

NCT Number: NCT01810419

Ultrasound Estimation of Spleen Size

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health (VCHRI/VCHA)

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vscan Ultrasound (GE Healthcare, USA)

Device

Vscan Ultrasound used to determine spleen size and the other qualities described in the arm description.

Other names: handheld ultrasound (HCU)

Conventional Ultrasound

Device

Conventional Ultrasound used to determine spleen size and the other qualities described in the arm description.

Other names: Gold standard, standard ultrasound, Ultrasonix

Primary outcomes

  1. longitudinal measure of spleen in centimeters

    Time frame: 1 day

Secondary outcomes

  1. Diagnosis of spleen size

    Time frame: 1 day

    Diagnosis

    • No Splenic Enlargement
    • Moderate Splenic Enlargement
    • Massive Splenic enlargement
  2. time to complete Vscan examination

    Time frame: 1 day

    Time to complete Vscan exam

    • <5min
    • 5-10 min
    • 10-15min
    • >15min

Other outcomes

  1. 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

    • Supine
    • Right Lateral Decubitus
  2. Diagnostic Certainty

    Time frame: 1 day

    Diagnostic Certainty

    • Not confident
    • Somewhat confident
    • Very confident

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Estimation of Spleen Size With Hand Held Ultrasound

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 13, 2013
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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