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

NCT01081210 | Completed DMC

• 2 other identifiers: LH-2010-1HD_2009_LU13
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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 both on behalf of the patients well-being, and for hospital logistic reasons.

1. 1.The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in an department of internal medicine.
2. 2.The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in a department of cardiology.
3. 3.As in 1), but examination by non-expert users compared to expert users.

Conditions

Heart Disease; Dyspnea; Aortic Disease; Kidney Disease; Liver Disease

Keywords

Echocardiography; Heart failure; Kidney; Lung; Aorta

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Non-experts

  After 3-6 months

Study Arms (1)

Ultrasound screening

Patients admitted to Department of medicine at local hospital. Randomized inclusion, informed consent obtained.

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Screening with bedside ultrasound examination

Also known as: GE Vingmed VScan

Ultrasound screening

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients admitted to Dep. of Medicine at Levanger Hospital

You may not qualify if:

• Not able to give informed consent

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust

Levanger, 7600, Norway

Location

Levanger Hospital, Department of Medicine

Levanger, N-7600, Norway

Location

Related Publications (6)

• 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.

  PMID: 17631091 BACKGROUND

• Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.

  PMID: 15522567 BACKGROUND

• 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.

  PMID: 17446784 BACKGROUND

• 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.

  PMID: 19670355 BACKGROUND

• 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.

  PMID: 19114170 BACKGROUND

• 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.

  PMID: 21810825 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples including; hematology, electrolytes, creatinine, liver enzymes and cholestasis parametres, brain natriuretic peptides etc.

MeSH Terms

Conditions

Heart Diseases; Dyspnea; Aortic Diseases; Kidney Diseases; Liver Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases

Study Officials

• Havard Dalen, MD

  Nord-Trøndelag Health Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 5, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

NO (2)