Influence of Routinely Adding Ultrasound Screening in Medical Department

NCT01331187 | Completed DMC

• 1 other identifier: LH-2011-1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Echocardiography; Heart failure; Ultrasonography; pocket-size device; Aorta; Education

Outcome Measures

Primary Outcomes (1)

• Time to definitive diagnosis

  Time from admittance to definitive diagnosis

  3 months

Secondary Outcomes (4)

• Test-retest reproducibility

  3 months

• Diagnostic outcome of additional ultrasound examination according to educational level of the performer

  3 months

• Time to definitive treatment

  3 months

• Time to discharge

  3 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care diagnostics. No routinely ultrasound examination

Other: Usual care

Routinely ulasonography

EXPERIMENTAL

Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics

Procedure: Pocket-size ultrasonography

Interventions

Pocket-size ultrasonography PROCEDURE

Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital

Routinely ulasonography

Usual care OTHER

No intervention, except for usual care (goal-directed diagnostics)

Usual care

Eligibility Criteria

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

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 (1)

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

Levanger, 7600, Norway

Location

Related Publications (7)

• 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.

  PMID: 21216764 BACKGROUND

• 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.

  PMID: 21126857 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

• 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

• 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

• Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

  PMID: 21345104 BACKGROUND

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, PhD

  Levanger Hospital/Norwegian University of Science an Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 7, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

NO (1)