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

Splenomegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02463669
• Other study ID #: POCUSIM01
• Status: Terminated
• Start date: April 2016
• Est. completion date: October 4, 2020

Study information

• Verified date: October 2020
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: October 4, 2020
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infection
• Infectious Mononucleosis
• Splenomegaly

Intervention

Device:
• Point-of-care ultrasound
Enrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound	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.	12 months