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Influence of Routinely Adding Ultrasound Screening in Medical Department

Primary Purpose

Heart Disease, Dyspnea, Aortic Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pocket-size ultrasonography
Usual care
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring Echocardiography, Heart failure, Ultrasonography, pocket-size device, Aorta, Education

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

  • Not able to give informed consent

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Routinely ulasonography

Arm Description

Usual care diagnostics. No routinely ultrasound examination

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

Outcomes

Primary Outcome Measures

Time to definitive diagnosis
Time from admittance to definitive diagnosis

Secondary Outcome Measures

Test-retest reproducibility
Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound.
Diagnostic outcome of additional ultrasound examination according to educational level of the performer
Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user
Time to definitive treatment
Time from admittance to definitive treatment
Time to discharge
Time from patients admittance to discharge from hospital

Full Information

First Posted
March 30, 2011
Last Updated
November 5, 2021
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01331187
Brief Title
Influence of Routinely Adding Ultrasound Screening in Medical Department
Official Title
Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2011 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Dyspnea, Aortic Disease, Kidney Disease, Liver Disease
Keywords
Echocardiography, Heart failure, Ultrasonography, pocket-size device, Aorta, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care diagnostics. No routinely ultrasound examination
Arm Title
Routinely ulasonography
Arm Type
Experimental
Arm Description
Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics
Intervention Type
Procedure
Intervention Name(s)
Pocket-size ultrasonography
Intervention Description
Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
No intervention, except for usual care (goal-directed diagnostics)
Primary Outcome Measure Information:
Title
Time to definitive diagnosis
Description
Time from admittance to definitive diagnosis
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Test-retest reproducibility
Description
Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound.
Time Frame
3 months
Title
Diagnostic outcome of additional ultrasound examination according to educational level of the performer
Description
Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user
Time Frame
3 months
Title
Time to definitive treatment
Description
Time from admittance to definitive treatment
Time Frame
3 months
Title
Time to discharge
Description
Time from patients admittance to discharge from hospital
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to Dep. of Medicine at Levanger Hospital Exclusion Criteria: Not able to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havard Dalen, MD, PhD
Organizational Affiliation
Levanger Hospital/Norwegian University of Science an Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
City
Levanger
ZIP/Postal Code
7600
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21216764
Citation
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.
Results Reference
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PubMed Identifier
21126857
Citation
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.
Results Reference
background
PubMed Identifier
15522567
Citation
Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.
Results Reference
background
PubMed Identifier
17631091
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. doi: 10.1016/j.amjcard.2007.02.104. Epub 2007 May 29.
Results Reference
background
PubMed Identifier
19670355
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.
Results Reference
background
PubMed Identifier
19114170
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.
Results Reference
background
PubMed Identifier
21345104
Citation
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.
Results Reference
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Influence of Routinely Adding Ultrasound Screening in Medical Department

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