Trial record 4 of 40 for:
The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
Verified July 2015 by Jewish General Hospital
Information provided by (Responsible Party):
Laurie Robichaud, Jewish General Hospital
First received: May 31, 2015
Last updated: July 21, 2015
Last verified: July 2015
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).
Device: Point-of-care ultrasound
||Observational Model: Cohort
Time Perspective: Prospective
||The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||10 Years to 35 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis
- 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)
- Inability to give informed consent
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No publications provided
||Laurie Robichaud, Laurie Robichaud, MD, Jewish General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 31, 2015
||July 21, 2015
||Canada: Ministère santé et services sociaux du Québec
Keywords provided by Jewish General Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2015
DNA Virus Infections
Epstein-Barr Virus Infections
Immune System Diseases
Pathological Conditions, Anatomical