Influence of Routinely Adding Ultrasound Screening in Medical Department

NCT ID: NCT01331187

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-01

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Disease Dyspnea Aortic Disease Kidney Disease Liver Disease

Keywords

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Echocardiography Heart failure Ultrasonography pocket-size device Aorta Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Usual care diagnostics. No routinely ultrasound examination

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Routinely ulasonography

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

Group Type EXPERIMENTAL

Pocket-size ultrasonography

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria

* Not able to give informed consent
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Havard Dalen, MD, PhD

Role: STUDY_CHAIR

Levanger Hospital/Norwegian University of Science an Technology

Locations

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

Levanger, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 21216764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21126857 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15522567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17631091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19670355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19114170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21345104 (View on PubMed)

Other Identifiers

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LH-2011-1

Identifier Type: -

Identifier Source: org_study_id