DyspneaNCT01287429
Lung Ultrasound for Acute Dyspnea in Emergency Department
An observational study of Dyspnea and Congestive Heart Failure, run by University of Turin, Italy at 7 sites in Italy.
Trial summary
Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Congestive Heart Failure
- What is being tested?
- lung and pleural ultrasound
- How many people
- 1,005 participants
- Where
- 7 sitesItaly
- Study dates
- Oct 2010to Oct 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital Emergency Departments sample
Who may be able to join
- Patients had to present to the ED with a principal complaint of shortness of breath, defined as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours;
- Presence of an emergency physician with lung US experience at the time of enrollment;
- US examination within 30 minutes after the start of the clinical evaluation.
Who cannot join
- Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Emergency Medicine & Surgery Unit - Cardinal Massaia Hospital
Asti, 14100
Emergency Department - AO Santa Croce e Carle
Cuneo
Emergency Medicine Unit - AOU San Luigi Gonzaga
Orbassano, 10043
Emergency Medicine & Surgery Unit - Pinerolo General Hospital, ASL TO 3
Pinerolo, 10064
Emergency Department - AOU San Giovanni Battista
Turin, Italy, 10126
Emergency Medicine and Surgery Unit- AO Mauriziano
Turin, 10128
Emergency Medicine & Surgery Unit - Martini Hospital, ASL TO 2
Turin, 10141
About this study
Official title: Lung Ultrasound for Acute Dyspnea in Emergency Department - Prospective Multicenter Study on Accuracy, Reproducibility, and Diagnostic Impact of Lung Ultrasound in the Evaluation of Patients With Dyspnea in the Emergency Department
Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.
- Conditions
- Dyspnea, Congestive Heart Failure
- Being tested
- lung and pleural ultrasound
- Keywords
- Ultrasonography
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung and pleural ultrasoundOther
After the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient.
| Study group | Role | What they receive |
|---|---|---|
| acute dyspnea | Not described Receives: Other: lung and pleural ultrasound |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Giovanni Battista, San Luigi Gonzaga Hospital, Agnelli Hospital, Italy, Azienda Ospedaliera Ordine Mauriziano di Torino, Martini Hospital, Turin, Italy, Ospedale Cardinal Massaia, Ospedale Santa Croce-Carle Cuneo
- Investigators
- Emanuele Pivetta, Principal investigator, Cancer Epidemiology Unit - University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287429
- Sponsor's protocol ID
- CEU-UTurin-001
- Status last verified
- Oct 2010
- First submitted
- 28 Jan 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. doi: 10.1186/cc4926. Epub 2006 May 24.
PubMed 16723034Dao Q, Krishnaswamy P, Kazanegra R, Harrison A, Amirnovin R, Lenert L, Clopton P, Alberto J, Hlavin P, Maisel AS. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol. 2001 Feb;37(2):379-85. doi: 10.1016/s0735-1097(00)01156-6.
PubMed 11216950Siefkin AD. Dyspnea in the elderly: cardiac or pulmonary? Geriatrics. 1985 May;40(5):63-5, 68-70, 73.
PubMed 3988043Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.
PubMed 12124404Incalzi RA, Fuso L, Serra M, Basso S, Carosella L, Tramaglino LM, Pistelli R, Carbonin P. Exacerbated chronic obstructive pulmonary disease: a frequently unrecognized condition. J Intern Med. 2002 Jul;252(1):48-55. doi: 10.1046/j.1365-2796.2002.01005.x.
PubMed 12074738Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
PubMed 16234501Fagan TJ. Letter: Nomogram for Bayes's theorem. N Engl J Med. 1975 Jul 31;293(5):257. doi: 10.1056/NEJM197507312930513. No abstract available.
PubMed 1143310Sackett DL, Straus S. On some clinically useful measures of the accuracy of diagnostic tests. ACP J Club. 1998 Sep-Oct;129(2):A17-9. doi: 10.7326/ACPJC-1998-129-2-A17. No abstract available.
PubMed 9749135Collins SP, Lindsell CJ, Storrow AB, Abraham WT; ADHERE Scientific Advisory Committee, Investigators and Study Group. Prevalence of negative chest radiography results in the emergency department patient with decompensated heart failure. Ann Emerg Med. 2006 Jan;47(1):13-8. doi: 10.1016/j.annemergmed.2005.04.003. Epub 2005 Jun 20.
PubMed 16387212Kataoka H, Takada S. The role of thoracic ultrasonography for evaluation of patients with decompensated chronic heart failure. J Am Coll Cardiol. 2000 May;35(6):1638-46. doi: 10.1016/s0735-1097(00)00602-1.
PubMed 10807471Lichtenstein D, Meziere G. A lung ultrasound sign allowing bedside distinction between pulmonary edema and COPD: the comet-tail artifact. Intensive Care Med. 1998 Dec;24(12):1331-4. doi: 10.1007/s001340050771.
PubMed 9885889Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.
PubMed 17316468Cardinale L, Volpicelli G, Binello F, Garofalo G, Priola SM, Veltri A, Fava C. Clinical application of lung ultrasound in patients with acute dyspnea: differential diagnosis between cardiogenic and pulmonary causes. Radiol Med. 2009 Oct;114(7):1053-64. doi: 10.1007/s11547-009-0451-1. Epub 2009 Aug 20.
PubMed 19697100Copetti R, Soldati G, Copetti P. Chest sonography: a useful tool to differentiate acute cardiogenic pulmonary edema from acute respiratory distress syndrome. Cardiovasc Ultrasound. 2008 Apr 29;6:16. doi: 10.1186/1476-7120-6-16.
PubMed 18442425Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.
PubMed 15135701
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound for Acute Dyspnea in Emergency Department - Prospective Multicenter Study on Accuracy, Reproducibility, and Diagnostic Impact of Lung Ultrasound in the Evaluation of Patients With Dyspnea in the Emergency Department
- ClinicalTrials.gov ID
- NCT01287429
- Acronym / sponsor ID
- CEU-UTurin-001
- Conditions
- Dyspnea, Congestive Heart Failure
- Keywords
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Giovanni Battista, San Luigi Gonzaga Hospital, Agnelli Hospital, Italy, Azienda Ospedaliera Ordine Mauriziano di Torino, Martini Hospital, Turin, Italy, Ospedale Cardinal Massaia, Ospedale Santa Croce-Carle Cuneo
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Feb 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.
Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute dyspnea | – | Other: lung and pleural ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital Emergency Departments sample
Key inclusion criteria (3 listed)
- Patients had to present to the ED with a principal complaint of shortness of breath, defined as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours;
- Presence of an emergency physician with lung US experience at the time of enrollment;
- US examination within 30 minutes after the start of the clinical evaluation.
Key exclusion criteria (1 listed)
- Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.
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 |
|---|---|---|
| lung and pleural ultrasoundAfter the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient. | Other | acute dyspnea |
Primary outcome
Not reported in the source record.
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 20 Nov 2012.
- Background: PubMed 16723034Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. doi: 10.1186/cc4926. Epub 2006 May 24.
- Background: PubMed 11216950Dao Q, Krishnaswamy P, Kazanegra R, Harrison A, Amirnovin R, Lenert L, Clopton P, Alberto J, Hlavin P, Maisel AS. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol. 2001 Feb;37(2):379-85. doi: 10.1016/s0735-1097(00)01156-6.
- Background: PubMed 3988043Siefkin AD. Dyspnea in the elderly: cardiac or pulmonary? Geriatrics. 1985 May;40(5):63-5, 68-70, 73.
- Background: PubMed 12124404Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.
- Background: PubMed 12074738Incalzi RA, Fuso L, Serra M, Basso S, Carosella L, Tramaglino LM, Pistelli R, Carbonin P. Exacerbated chronic obstructive pulmonary disease: a frequently unrecognized condition. J Intern Med. 2002 Jul;252(1):48-55. doi: 10.1046/j.1365-2796.2002.01005.x.
- Background: PubMed 16234501Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
- Background: PubMed 1143310Fagan TJ. Letter: Nomogram for Bayes's theorem. N Engl J Med. 1975 Jul 31;293(5):257. doi: 10.1056/NEJM197507312930513. No abstract available.
- Background: PubMed 9749135Sackett DL, Straus S. On some clinically useful measures of the accuracy of diagnostic tests. ACP J Club. 1998 Sep-Oct;129(2):A17-9. doi: 10.7326/ACPJC-1998-129-2-A17. No abstract available.
- Background: PubMed 16387212Collins SP, Lindsell CJ, Storrow AB, Abraham WT; ADHERE Scientific Advisory Committee, Investigators and Study Group. Prevalence of negative chest radiography results in the emergency department patient with decompensated heart failure. Ann Emerg Med. 2006 Jan;47(1):13-8. doi: 10.1016/j.annemergmed.2005.04.003. Epub 2005 Jun 20.
- Background: PubMed 10807471Kataoka H, Takada S. The role of thoracic ultrasonography for evaluation of patients with decompensated chronic heart failure. J Am Coll Cardiol. 2000 May;35(6):1638-46. doi: 10.1016/s0735-1097(00)00602-1.
- Background: PubMed 9885889Lichtenstein D, Meziere G. A lung ultrasound sign allowing bedside distinction between pulmonary edema and COPD: the comet-tail artifact. Intensive Care Med. 1998 Dec;24(12):1331-4. doi: 10.1007/s001340050771.
- Background: PubMed 17316468Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.
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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.
Emanuele Pivetta principal investigator
Cancer Epidemiology Unit - University of Turin
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Congestive Heart Failure, run by University of Turin, Italy at 7 sites in Italy.
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 3 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 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287429, which also lists 25 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 20 Nov 2012.