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Trial record 4 of 42 for:    mononucleosis

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

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ClinicalTrials.gov Identifier: NCT02463669
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Laurie Robichaud, Jewish General Hospital

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
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 Type : Observational
Estimated Enrollment : 280 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 : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound [ Time Frame: 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.



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Ages Eligible for Study:   10 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463669


Locations
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C4
Contact: Laurie Robichaud, MD    514-772-5827    laurie.robichaud@mail.mcgill.ca   
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Laurie Robichaud, MD    514-772-5827    laurie.robichaud@mail.mcgill.ca   
Sponsors and Collaborators
Jewish General Hospital

Responsible Party: Laurie Robichaud, Laurie Robichaud, MD, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02463669     History of Changes
Other Study ID Numbers: POCUSIM01
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Laurie Robichaud, Jewish General Hospital:
Point-of-care ultrasound

Additional relevant MeSH terms:
Infectious Mononucleosis
Emergencies
Communicable Diseases
Infection
Splenomegaly
Disease Attributes
Pathologic Processes
Hypertrophy
Pathological Conditions, Anatomical
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Leukocyte Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases