Ultrasound Estimation of Spleen Size

Splenomegaly Clinical Trial

Official title:

Estimation of Spleen Size With Hand Held Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810419
• Other study ID #: H12-03055
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: April 12, 2017
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Splenomegaly

Intervention

Device:
• Vscan Ultrasound (GE Healthcare, USA)
Vscan Ultrasound used to determine spleen size and the other qualities described in the arm description.
• Conventional Ultrasound
Conventional Ultrasound used to determine spleen size and the other qualities described in the arm description.

Locations

Country	Name	City	State
Canada	Vancouver Coastal Health (VCHRI/VCHA)	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Image quality and best views	Adequacy of study; Image quality inadequate to make diagnosis; Image quality adequate; Image quality excellent; Best Views obtained; Supine; Right Lateral Decubitus	1 day
Other	Diagnostic Certainty	Diagnostic Certainty; Not confident; Somewhat confident; Very confident	1 day
Primary	longitudinal measure of spleen in centimeters		1 day
Secondary	Diagnosis of spleen size	Diagnosis; No Splenic Enlargement; Moderate Splenic Enlargement; Massive Splenic enlargement	1 day
Secondary	time to complete Vscan examination	Time to complete Vscan exam; <5min; 5-10 min; 10-15min; >15min	1 day