The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department

Sponsor

Jewish General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02463669

Collaborator

(none)

200

Enrollment

Locations

54.1

Duration (Months)

100

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).

Condition or Disease	Intervention/Treatment	Phase
Infectious Mononucleosis Splenomegaly	Device: Point-of-care ultrasound

Detailed Description

The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Oct 4, 2020

Actual Study Completion Date :

Oct 4, 2020

Outcome Measures

Primary Outcome Measures

Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound [12 months]
Splenomegaly is defined as a splenic length of > 11.5 centimetres (cm) for 10-12 year-old patients, > 12 cm for 12-15 year-old patients, > 12 cm for 15-35 year-old female patients, and > 13 cm for 15-35 year-old male patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis

Exclusion Criteria:

Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
Storage diseases (eg. Gaucher, Niemann-Pick)
Splenectomy
Inability to give informed consent