Trial record 3 of 18 for:    "Splenomegaly"

Estimation of Spleen by Residents With VScan

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01907932
First received: July 22, 2013
Last updated: March 10, 2014
Last verified: March 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 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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Estimation of Spleen Size by Medical Residents With Hand Carried 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


Other Outcome Measures:
  • 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

  • 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

    a. Supine b. 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


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01907932     History of Changes
Other Study ID Numbers: H13-01727
Study First Received: July 22, 2013
Last Updated: March 10, 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 April 15, 2014