Heart DiseaseNCT01331187
Influence of Routinely Adding Ultrasound Screening in Medical Department
A study testing Pocket-size ultrasonography in people with Heart Disease and Dyspnea, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Heart Disease, Dyspnea, Aortic Disease
- What is being tested?
- Pocket-size ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to Dep. of Medicine at Levanger Hospital
Who cannot join
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, 7600
About this study
Official title: Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department
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.
- 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
- Being tested
- Pocket-size ultrasonography, Usual care
- Keywords
- Echocardiography, Heart failure, Ultrasonography, pocket-size device, Aorta, Education
- Medical subject headings
- Heart Diseases, Dyspnea, Aortic Diseases, Kidney Diseases, Liver Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket-size ultrasonographyProcedure or surgery
Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital
Usual careOther
No intervention, except for usual care (goal-directed diagnostics)
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care diagnostics. No routinely ultrasound examination Receives: Other: Usual care |
| Routinely ulasonography | Experimental | Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics Receives: Procedure: Pocket-size ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to definitive diagnosis
Time from admittance to definitive diagnosis
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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
Measured: 3 months
Time to definitive treatment
Time from admittance to definitive treatment
Measured: 3 months
Time to discharge
Time from patients admittance to discharge from hospital
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study start1 Apr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Havard Dalen, MD, PhD, Study chair, Levanger Hospital/Norwegian University of Science an Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331187
- Sponsor's protocol ID
- LH-2011-1
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2011
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21216764Prinz 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.
PubMed 21126857Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.
PubMed 15522567Kimura 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.
PubMed 17631091Lucas 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.
PubMed 19670355Martin 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.
PubMed 19114170Moore 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.
PubMed 21345104
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department
- ClinicalTrials.gov ID
- NCT01331187
- Acronym / sponsor ID
- LH-2011-1
- Conditions
- Heart Disease, Dyspnea, Aortic Disease, Kidney Disease, Liver Disease
- Keywords
- Echocardiography, Heart failure, Ultrasonography, pocket-size device, Aorta, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual care diagnostics. No routinely ultrasound examination |
| Routinely ulasonography | Experimental | Procedure: Pocket-size ultrasonographyPatients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to Dep. of Medicine at Levanger Hospital
Key exclusion criteria (1 listed)
- Not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket-size ultrasonographyRoutinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital | Procedure or surgery | Routinely ulasonography |
| Usual careNo intervention, except for usual care (goal-directed diagnostics) | Other | Usual care |
Primary outcome
Time to definitive diagnosis
Time frame: 3 months
Time from admittance to definitive diagnosis
4 secondary outcomes
Test-retest reproducibility
Time frame: 3 months
Diagnostic outcome of additional ultrasound examination according to educational level of the performer
Time frame: 3 months
Time to definitive treatment
Time frame: 3 months
Time to discharge
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Background: PubMed 21216764Sicari 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.
- Background: PubMed 21126857Prinz 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.
- Background: PubMed 15522567Roelandt JR. Ultrasound stethoscopy. Eur J Intern Med. 2004 Oct;15(6):337-347. doi: 10.1016/j.ejim.2004.08.002.
- Background: PubMed 17631091Kimura 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.
- Background: PubMed 19670355Lucas 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.
- Background: PubMed 19114170Martin 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.
- Background: PubMed 21345104Moore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Havard Dalen, MD, PhD study chair
Levanger Hospital/Norwegian University of Science an Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket-size ultrasonography in people with Heart Disease and Dyspnea, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to definitive diagnosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331187, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.