search
Back to results

Ultrasound Estimation of Spleen Size

Primary Purpose

Splenomegaly

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vscan Ultrasound (GE Healthcare, USA)
Conventional Ultrasound
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Splenomegaly focused on measuring splenomegaly, ultrasound, Vscan

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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) 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: 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
time to complete Vscan examination
Time to complete Vscan exam <5min 5-10 min 10-15min >15min

Full Information

First Posted
March 7, 2013
Last Updated
April 12, 2017
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01810419
Brief Title
Ultrasound Estimation of Spleen Size
Official Title
Estimation of Spleen Size With Hand Held Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

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 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.
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.

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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal and various degrees splenomegaly
Arm Type
Experimental
Arm Description
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: 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.
Intervention Type
Device
Intervention Name(s)
Conventional Ultrasound
Other Intervention Name(s)
Gold standard, standard ultrasound, Ultrasonix
Intervention Description
Conventional 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
Title
time to complete Vscan examination
Description
Time to complete Vscan exam <5min 5-10 min 10-15min >15min
Time Frame
1 day
Other Pre-specified Outcome Measures:
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 Supine 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 (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
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

Ultrasound Estimation of Spleen Size

We'll reach out to this number within 24 hrs