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Estimation of Spleen by Residents With VScan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01907932
First Posted: July 25, 2013
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Graydon Meneilly, University of British Columbia
  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 the 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 medical residents can be taught to use hand carried ultrasound to accurately assess spleen size. Doing so would make physical examination of the spleen obsolete and transform training objectives for medical trainees.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Estimation of Spleen Size by Medical Residents With Hand Carried Ultrasound

Resource links provided by NLM:


Further study details as provided by Graydon Meneilly, University of British Columbia:

Primary Outcome Measures:
  • longitudinal measure of spleen in centimeters [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Diagnosis of spleen size [ Time Frame: 1 day ]

    Diagnosis

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


Other Outcome Measures:
  • 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

  • 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

    a. Supine b. Right Lateral Decubitus


  • Diagnostic Certainty [ Time Frame: 1 day ]

    Diagnostic Certainty

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


Enrollment: 29
Actual Study Start Date: November 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: normal and various degrees splenomegaly

VScan Ultrasound (GE Healthcare, USA) all subjects will be measured by 5 different medical residents

Each resident will complete questionaire:

  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)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients in the practices of hematologists at VGH 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
Information from the National Library of Medicine

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): NCT01907932


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

Responsible Party: Graydon Meneilly, Professor, UBC Department of Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT01907932     History of Changes
Other Study ID Numbers: H13-01727
First Submitted: July 22, 2013
First Posted: July 25, 2013
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Graydon Meneilly, University of British Columbia:
splenomegaly
ultrasound
VScan

Additional relevant MeSH terms:
Splenomegaly
Hypertrophy
Pathological Conditions, Anatomical