The Role of Contrast Enhanced Ultrasound in Appendicitis

Phase 2

Completed

Brief Summary: This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.

Detailed Description: This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis.

For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.

Recruitment & Eligibility

Inclusion Criteria

Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
Age 8 through 17 years
seen between Institutional Review Board (IRB) approval date and 12/31/2019
Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
Has had an IV catheter placed as part of their standard of care

Exclusion Criteria

Known cardiac abnormality
Pulmonary hypertension
Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
Does not had an IV catheter placed
Unable to roll over
Unable to assent
Pregnant
Lactating
Received an ultrasound image from a referring facility

Arm && Interventions

Group	Intervention	Description
Experimental	Sulfur hexafluoride lipid-type A microspheres	IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, up to 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.

Primary Outcome Measures

Name	Time	Method
Number of Children With an Accurate Diagnosis of Appendicitis.	1 week	Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories: Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis

Secondary Outcome Measures

Name	Time	Method
Definitive Diagnosis	1 week	Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Number of Participants Who Required Additional CT Scan	30 days	"Number of Participants who Required Additional CT Scan"
Percentage of Negative Appendectomies	1 week	Percentage of negative appendectomies
Total Cost Difference Compared to Traditional Ultrasound	60 days	Costs in comparison to traditional ultrasound
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.	60 days	Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.