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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01331187
Other study ID # LH-2011-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2011
Est. completion date June 2011

Study information

Verified date November 2021
Source Helse Nord-Trøndelag HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Patients admitted to Dep. of Medicine at Levanger Hospital Exclusion Criteria: - Not able to give informed consent

Study Design


Intervention

Procedure:
Pocket-size ultrasonography
Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital
Other:
Usual care
No intervention, except for usual care (goal-directed diagnostics)

Locations

Country Name City State
Norway Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust Levanger

Sponsors (2)

Lead Sponsor Collaborator
Helse Nord-Trøndelag HF Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (7)

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. Epub 2007 May 29. — View 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. — View 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. — View Citation

Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review. — View 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. — View Citation

Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to definitive diagnosis Time from admittance to definitive diagnosis 3 months
Secondary Test-retest reproducibility Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound. 3 months
Secondary Diagnostic outcome of additional ultrasound examination according to educational level of the performer Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user 3 months
Secondary Time to definitive treatment Time from admittance to definitive treatment 3 months
Secondary Time to discharge Time from patients admittance to discharge from hospital 3 months
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