Ultrasound Estimation of Spleen Size

NCT01810419 | Completed DMC

• 1 other identifier: H12-03055
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Splenomegaly

Keywords

splenomegaly; ultrasound; Vscan

Outcome Measures

Primary Outcomes (1)

• longitudinal measure of spleen in centimeters

  1 day

Secondary Outcomes (2)

• Diagnosis of spleen size

  1 day

• time to complete Vscan examination

  1 day

Other Outcomes (2)

• Image quality and best views

  1 day

• Diagnostic Certainty

  1 day

Study Arms (1)

normal and various degrees splenomegaly

EXPERIMENTAL

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: 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); Device: Conventional Ultrasound

Interventions

Vscan Ultrasound (GE Healthcare, USA) DEVICE

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

Also known as: handheld ultrasound (HCU)

normal and various degrees splenomegaly

Conventional Ultrasound DEVICE

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

Also known as: Gold standard, standard ultrasound, Ultrasonix

normal and various degrees splenomegaly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Coastal Health (VCHRI/VCHA)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Splenomegaly

Condition Hierarchy (Ancestors)

Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Graydon S Meneilly, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, FACP, Professor & Eric W. Hamber Chair

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)