Influence of Routinely Adding Ultrasound Screening in Medical Department

Dyspnea Clinical Trial

Official title:

Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331187
• Other study ID #: LH-2011-1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aortic Disease
• Aortic Diseases
• Dyspnea
• Heart Disease
• Heart Diseases
• Kidney Disease
• Kidney Diseases
• Liver Disease
• Liver Diseases

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

External Links

•   Article; Point of care ultrasonography, New England Journal of Medicine 2011