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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease; Liver Disease; Dyspnea; Kidney Disease; Aortic Disease
• Intervention / Treatment: Other: Ultrasound examination

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway, 7600
    • Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
  • Levanger, Norway, N-7600
    • Levanger Hospital, Department of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to Dep. of Medicine at Levanger Hospital Randomized study. Both sexes. Age above 16 years

Description

Inclusion Criteria:

• Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

• Not able to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound screening; Patients admitted to Department of medicine at local hospital. Randomized inclusion, informed consent obtained.	Other: Ultrasound examination; Screening with bedside ultrasound examination; Other Names: GE Vingmed VScan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-experts	Validation of results from ultrasound examination made by non-experts compared to expert users.	After 3-6 months

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Havard Dalen, MD, Nord-Trøndelag Health Trust

Publications and helpful links

General Publications

• 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.
• Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.
• 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.
• 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.
• Beaulieu Y. Bedside echocardiography in the assessment of the critically ill. Crit Care Med. 2007 May;35(5 Suppl):S235-49. doi: 10.1097/01.CCM.0000260673.66681.AF.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; Lung; Echocardiography; Kidney; Aorta
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Urologic Diseases; Signs and Symptoms, Respiratory; Liver Diseases; Heart Diseases; Kidney Diseases; Dyspnea; Aortic Diseases
• Other Study ID Numbers: LH-2010-1; HD_2009_LU13 (Other Identifier: Nord-Trøndelag Health Trust)