AzTrials
AzTrials

SplenomegalyNCT01907932

Estimation of Spleen by Residents With VScan

A study testing VScan Ultrasound (GE Healthcare, USA) in people with Splenomegaly, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Splenomegaly
What is being tested?
VScan Ultrasound (GE Healthcare, USA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteCanada
Study dates
Nov 2013to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patients in the practices of hematologists at VGH who are expected to have normal size spleens as well as various degrees of splenomegaly

Who cannot join

  • will exclude patients who cannot speak English or who cannot give informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Vancouver Coastal Health (VCHRI/VCHA)

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Estimation of Spleen Size by Medical Residents With Hand Carried Ultrasound

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.

Read the 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.

Conditions
Splenomegaly
Being tested
VScan Ultrasound (GE Healthcare, USA)
Keywords
splenomegaly, ultrasound, VScan
Medical subject headings
Splenomegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VScan Ultrasound (GE Healthcare, USA)Device

    Also called handheld ultrasound (HCU)

    VScan Ultrasound used to determine spleen size and the other qualities described in the arm description.

Study groups in NCT01907932
Study groupRoleWhat they receive
normal and various degrees splenomegalyExperimentalVScan 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
Receives: Device: VScan Ultrasound (GE Healthcare, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. longitudinal measure of spleen in centimeters

    Measured: 1 day

Secondary outcomes (1)
  1. Diagnosis of spleen size

    Diagnosis

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01907932
Sponsor's protocol ID
H13-01727
Status last verified
Apr 2017
First submitted
22 Jul 2013
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VScan Ultrasound (GE Healthcare, USA) in people with Splenomegaly, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

longitudinal measure of spleen in centimeters (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in