Clinical trial NCT01081210: Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound
Official title: Screening With Pocket-sized Ultrasound of Patients Admitted to Department of Medicine at a Local Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Dyspnea
Aortic Disease
Kidney Disease
Liver Disease
Keywords: Echocardiography
Heart failure
Kidney
Lung
Aorta
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2010-03-05
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Dep. of Medicine at Levanger Hospital Randomized study. Both sexes. Age above 16 years

Brief summary: Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients well-being, and for hospital logistic reasons.

1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in an department of internal medicine.

   Method: All patients admitted (in certain preset periods) to Department of medicine will be screened with pocket sized US by expert user. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.
2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in a department of cardiology.

   Method: All patients admitted (in certain preset periods) to Department of cardiology will be screened with pocket sized US for heart disease, pericardial and pleural effusion. Examinations by expert users. Specific findings could be myocardial dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia, valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography in all.
3. As in 1), but examination by non-expert users compared to expert users.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

* Not able to give informed consent

Primary outcomes:
measure: Diagnostic sensitivity and specificity
timeFrame: After 3-6 months
Secondary outcomes:
measure: Non-experts
timeFrame: After 3-6 months
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
city: Levanger
country: Norway
facility: Levanger Hospital, Department of Medicine
Study officials:
affiliation: Nord-Trøndelag Health Trust
name: Havard Dalen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lucas BP, Candotti C, Margeta B, Evans AT, Mba B, Baru J, Asbury JK, Asmar A, Kumapley R, Patel M, Borkowsky S, Fung S, Charles-Damte M. Diagnostic accuracy of hospitalist-performed hand-carried ultrasound echocardiography after a brief training program. J Hosp Med. 2009 Jul;4(6):340-9. doi: 10.1002/jhm.438.
citation: Martin LD, Howell EE, Ziegelstein RC, Martire C, Whiting-O'Keefe QE, Shapiro EP, Hellmann DB. Hand-carried ultrasound performed by hospitalists: does it improve the cardiac physical examination? Am J Med. 2009 Jan;122(1):35-41. doi: 10.1016/j.amjmed.2008.07.022.
citation: Andersen GN, Haugen BO, Graven T, Salvesen O, Mjolstad OC, Dalen H. Feasibility and reliability of point-of-care pocket-sized echocardiography. Eur J Echocardiogr. 2011 Sep;12(9):665-70. doi: 10.1093/ejechocard/jer108. Epub 2011 Aug 2.