Estimation of Spleen by Residents With VScan
Primary Purpose
Splenomegaly
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VScan Ultrasound (GE Healthcare, USA)
Sponsored by
About this trial
This is an interventional other trial for Splenomegaly focused on measuring splenomegaly, ultrasound, VScan
Eligibility 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
Sites / Locations
- Vancouver Coastal Health (VCHRI/VCHA)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
normal and various degrees splenomegaly
Arm Description
VScan Ultrasound (GE Healthcare, USA) all subjects will be measured by 5 different medical residents Each resident will complete questionaire: Adequacy of image quality What is best view obtained Greatest Longitudinal Measure Diagnosis Diagnostic Certainty Time to Complete exam
Outcomes
Primary Outcome Measures
longitudinal measure of spleen in centimeters
Secondary Outcome Measures
Diagnosis of spleen size
Diagnosis
No Splenic Enlargement
Moderate Splenic Enlargement
Massive Splenic enlargement
Full Information
NCT ID
NCT01907932
First Posted
July 22, 2013
Last Updated
April 12, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01907932
Brief Title
Estimation of Spleen by Residents With VScan
Official Title
Estimation of Spleen Size by Medical Residents With Hand Carried Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The diagnosis of splenomegaly is extremely important in managing patients with blood disorders and other medical conditions, such as cirrhosis. The ability to recognize an enlarged spleen in a timely manner can impact patient outcomes. Although the physical exam can be confidently used to 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 conventional abdominal ultrasound. The prevalence of splenomegaly in patients with blood conditions and other medical disorders is relatively high. Therefore, the demand for abdominal ultrasound is growing and similarly the cost of caring for patients with these conditions.
In addition, examination of the spleen is one of the core competencies that the investigators expect the students and residents to learn as part of their training. This physical diagnosis maneuver 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 hand carried ultrasound (HCU) devices, rapid bedside assessment of a patient is now possible. The Visual scan (VScan) (GE Healthcare, USA) allows for 2D imaging on a 3.5 inch display and has shown to have comparable image quality to standard ultrasound for some applications. The VScan and other HCU 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. The investigators conducted an extensive literature review and the investigators were unable to find any studies attempting to accurately assess spleen size with HCU. The investigators recently demonstrated that trained ultrasonographers can reliably assess spleen size at the bedside using a VScan. The current study aims to determine the diagnostic accuracy of the VScan when used by medical residents who have been trained in its use, in patients with varying degrees of splenomegaly, including normal spleen size. If the investigators can show that medical residents can accurately characterize spleen size at the bedside with a hand carried device, the next stage of the study will be to determine how the investigators can integrate HCU with physical examination at the bedside to assess spleen size.
Design, Specification of Endpoints, and Procedures:
The investigators propose a validation study in 50 patients who have medical conditions that may result in varying degrees of splenomegaly (including normal spleen size) and who are looked after in the hematology clinics at Vancouver General Hospital (VGH). Patients will be recruited based on information provided in the charts in the private offices of hematologists at VGH.
The investigators will also enroll 20 first year medical residents. First year residents will be sent a letter by email describing the study.
Each medical resident will undergo a one hour training sessions by an ultrasonographer regarding the use of HCU to assess spleen size. At the end of the session, they will be evaluated by the sonographer to make sure they know how to use the HCU to acquire images of the spleen. If they are not proficient they will undergo a subsequent one hour training session. On a separate day, a trained ultrasonographer will perform a conventional ultrasound on each patient to accurately measure their spleen size. This information will be provided to the patients hematologist. Subsequently residents will attempt to measure the size of the patient's spleen using the VScan. Each patient will be scanned 5 times by 5 different residents. Each resident will be blinded as to the patient's underlying medical conditions and the results of previous scans. Variables of interest include: adequacy of the study, findings on 2D imaging, overall diagnosis of presence of splenomegaly, confidence level in diagnosis and time to complete test.
The goal is to determine if medical residents can use a hand carried ultrasound device to accurately assess spleen size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Splenomegaly
Keywords
splenomegaly, ultrasound, VScan
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal and various degrees splenomegaly
Arm Type
Experimental
Arm Description
VScan Ultrasound (GE Healthcare, USA) all subjects will be measured by 5 different medical residents
Each resident will complete questionaire:
Adequacy of image quality
What is best view obtained
Greatest Longitudinal Measure
Diagnosis
Diagnostic Certainty
Time to Complete exam
Intervention Type
Device
Intervention Name(s)
VScan Ultrasound (GE Healthcare, USA)
Other Intervention Name(s)
handheld ultrasound (HCU)
Intervention Description
VScan Ultrasound used to determine spleen size and the other qualities described in the arm description.
Primary Outcome Measure Information:
Title
longitudinal measure of spleen in centimeters
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Diagnosis of spleen size
Description
Diagnosis
No Splenic Enlargement
Moderate Splenic Enlargement
Massive Splenic enlargement
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
time to complete VScan examination
Description
Time to complete VScan exam
<5min
5-10 min
10-15min
>15min
Time Frame
1 day
Title
Image quality and best views
Description
Adequacy of study
Image quality inadequate to make diagnosis
Image quality adequate
Image quality excellent Best Views obtained
a. Supine b. Right Lateral Decubitus
Time Frame
1 day
Title
Diagnostic Certainty
Description
Diagnostic Certainty
Not confident
Somewhat confident
Very confident
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graydon S Meneilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Coastal Health (VCHRI/VCHA)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Estimation of Spleen by Residents With VScan
We'll reach out to this number within 24 hrs