Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound

Dyspnea Clinical Trial

Official title:

Screening With Pocket-sized Ultrasound of Patients Admitted to Department of Medicine at a Local Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081210
• Other study ID #: LH-2010-1
• Secondary ID: HD_2009_LU13
• Status: Completed
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2021
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 110 Years

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

Other:
• Ultrasound examination
Screening with bedside ultrasound examination

Locations

Country	Name	City	State
Norway	Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust	Levanger
Norway	Levanger Hospital, Department of Medicine	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 (5)

Beaulieu Y. Bedside echocardiography in the assessment of the critically ill. Crit Care Med. 2007 May;35(5 Suppl):S235-49. Review. — View 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. 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity and specificity	Diagnostic accuracy and clinical usefulness of ultrasound screening as add on examination. Change in working diagnosis after ultrasound examination will be tested, and gold standards (echocardiography and examinations at Department of radiology) will be used for testing of sensitivity and specificity.	After 3-6 months
Secondary	Non-experts	Validation of results from ultrasound examination made by non-experts compared to expert users.	After 3-6 months