Trial record 2 of 18 for:    "Splenomegaly"

Ultrasound Estimation of Spleen Size

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01810419
First received: March 7, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Splenomegaly
Device: Vscan Ultrasound (GE Healthcare, USA)
Device: Conventional Ultrasound

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Estimation of Spleen Size With Hand Held Ultrasound

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • longitudinal measure of spleen in centimeters [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnosis of spleen size [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    Diagnosis

    1. No Splenic Enlargement
    2. Moderate Splenic Enlargement
    3. Massive Splenic enlargement

  • time to complete Vscan examination [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    Time to complete Vscan exam

    1. <5min
    2. 5-10 min
    3. 10-15min
    4. >15min


Other Outcome Measures:
  • Image quality and best views [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Diagnostic Certainty

    1. Not confident
    2. Somewhat confident
    3. Very confident


Enrollment: 16
Study Start Date: March 2013
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810419

Locations
Canada, British Columbia
Vancouver Coastal Health (VCHRI/VCHA)
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Graydon S Meneilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01810419     History of Changes
Other Study ID Numbers: H12-03055
Study First Received: March 7, 2013
Last Updated: July 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
splenomegaly
ultrasound
Vscan

Additional relevant MeSH terms:
Splenomegaly
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014