Trial record 4 of 40 for:    mononucleosis

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Jewish General Hospital
Sponsor:
Information provided by (Responsible Party):
Laurie Robichaud, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT02463669
First received: May 31, 2015
Last updated: July 21, 2015
Last verified: July 2015
  Purpose

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 Intervention
Infectious Mononucleosis
Splenomegaly
Device: Point-of-care ultrasound

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 280
Study Start Date: October 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   10 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Convenience sample of patients between October 2015 and November 2016. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Laurie Robichaud, Laurie Robichaud, MD, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02463669     History of Changes
Other Study ID Numbers: POCUSIM01
Study First Received: May 31, 2015
Last Updated: July 21, 2015
Health Authority: Canada: Ministère santé et services sociaux du Québec

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

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

ClinicalTrials.gov processed this record on July 29, 2015