Clinical trial NCT01331187: Influence of Routinely Adding Ultrasound Screening in Medical Department
Official title: Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Dyspnea
Aortic Disease
Kidney Disease
Liver Disease
Keywords: Echocardiography
Heart failure
Ultrasonography
pocket-size device
Aorta
Education
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2011-04-07
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with respect to the patients well-being and inpatients workflow.

1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in an medical department with respect to inpatients workflow and diagnostics.

Method: Patients admitted (in certain preset periods) to Department of medicine will be randomized to routinely adding an ultrasound examination with pocket-size device by residents on call. Time to definitive diagnosis, time to definitive treatment and time to discard will be recorded. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

* Not able to give informed consent

Primary outcomes:
measure: Time to definitive diagnosis
timeFrame: 3 months
Secondary outcomes:
measure: Test-retest reproducibility
timeFrame: 3 months
measure: Diagnostic outcome of additional ultrasound examination according to educational level of the performer
timeFrame: 3 months
measure: Time to definitive treatment
timeFrame: 3 months
measure: Time to discharge
timeFrame: 3 months
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Study officials:
affiliation: Levanger Hospital/Norwegian University of Science an Technology
name: Havard Dalen, MD, PhD
role: STUDY_CHAIR
References:
citation: Sicari R, Galderisi M, Voigt JU, Habib G, Zamorano JL, Lancellotti P, Badano LP. The use of pocket-size imaging devices: a position statement of the European Association of Echocardiography. Eur J Echocardiogr. 2011 Feb;12(2):85-7. doi: 10.1093/ejechocard/jeq184. Epub 2011 Jan 7.
citation: Prinz C, Voigt JU. Diagnostic accuracy of a hand-held ultrasound scanner in routine patients referred for echocardiography. J Am Soc Echocardiogr. 2011 Feb;24(2):111-6. doi: 10.1016/j.echo.2010.10.017. Epub 2010 Dec 3.
citation: Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.
citation: Kimura BJ, Shaw DJ, Agan DL, Amundson SA, Ping AC, DeMaria AN. Value of a cardiovascular limited ultrasound examination using a hand-carried ultrasound device on clinical management in an outpatient medical clinic. Am J Cardiol. 2007 Jul 15;100(2):321-5. doi: 10.1016/j.amjcard.2007.02.104. Epub 2007 May 29.
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: Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.