Lung Ultrasound for Acute Dyspnea in Emergency Department

NCT ID: NCT01287429

Last Updated: 2012-11-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1005 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspnea Congestive Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasonography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

acute dyspnea

lung and pleural ultrasound

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lung and pleural ultrasound

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role collaborator

San Luigi Gonzaga Hospital

OTHER

Sponsor Role collaborator

Agnelli Hospital, Italy

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role collaborator

Martini Hospital, Turin, Italy

OTHER

Sponsor Role collaborator

Ospedale Cardinal Massaia

OTHER

Sponsor Role collaborator

Ospedale Santa Croce-Carle Cuneo

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cancer Epidemiology Unit - University of Turin

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emanuele Pivetta

Role: PRINCIPAL_INVESTIGATOR

Cancer Epidemiology Unit - University of Turin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emergency Department - AOU San Giovanni Battista

Turin, Italy, Italy

Site Status

Emergency Medicine & Surgery Unit - Cardinal Massaia Hospital

Asti, , Italy

Site Status

Emergency Department - AO Santa Croce e Carle

Cuneo, , Italy

Site Status

Emergency Medicine Unit - AOU San Luigi Gonzaga

Orbassano, , Italy

Site Status

Emergency Medicine & Surgery Unit - Pinerolo General Hospital, ASL TO 3

Pinerolo, , Italy

Site Status

Emergency Medicine and Surgery Unit- AO Mauriziano

Turin, , Italy

Site Status

Emergency Medicine & Surgery Unit - Martini Hospital, ASL TO 2

Turin, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16723034 (View on PubMed)

Dao 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.

Reference Type BACKGROUND
PMID: 11216950 (View on PubMed)

Siefkin AD. Dyspnea in the elderly: cardiac or pulmonary? Geriatrics. 1985 May;40(5):63-5, 68-70, 73.

Reference Type BACKGROUND
PMID: 3988043 (View on PubMed)

Maisel 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.

Reference Type BACKGROUND
PMID: 12124404 (View on PubMed)

Incalzi 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.

Reference Type BACKGROUND
PMID: 12074738 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 16234501 (View on PubMed)

Fagan TJ. Letter: Nomogram for Bayes's theorem. N Engl J Med. 1975 Jul 31;293(5):257. doi: 10.1056/NEJM197507312930513. No abstract available.

Reference Type BACKGROUND
PMID: 1143310 (View on PubMed)

Sackett DL, Straus S. On some clinically useful measures of the accuracy of diagnostic tests. ACP J Club. 1998 Sep-Oct;129(2):A17-9. No abstract available.

Reference Type BACKGROUND
PMID: 9749135 (View on PubMed)

Collins 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.

Reference Type BACKGROUND
PMID: 16387212 (View on PubMed)

Kataoka 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.

Reference Type BACKGROUND
PMID: 10807471 (View on PubMed)

Lichtenstein 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.

Reference Type BACKGROUND
PMID: 9885889 (View on PubMed)

Bouhemad 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.

Reference Type BACKGROUND
PMID: 17316468 (View on PubMed)

Cardinale 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.

Reference Type BACKGROUND
PMID: 19697100 (View on PubMed)

Copetti 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.

Reference Type BACKGROUND
PMID: 18442425 (View on PubMed)

Jambrik 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.

Reference Type BACKGROUND
PMID: 15135701 (View on PubMed)

Lichtenstein DA. Ultrasound in the management of thoracic disease. Crit Care Med. 2007 May;35(5 Suppl):S250-61. doi: 10.1097/01.CCM.0000260674.60761.85.

Reference Type BACKGROUND
PMID: 17446785 (View on PubMed)

Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.

Reference Type BACKGROUND
PMID: 18403664 (View on PubMed)

Picano E, Frassi F, Agricola E, Gligorova S, Gargani L, Mottola G. Ultrasound lung comets: a clinically useful sign of extravascular lung water. J Am Soc Echocardiogr. 2006 Mar;19(3):356-63. doi: 10.1016/j.echo.2005.05.019.

Reference Type BACKGROUND
PMID: 16500505 (View on PubMed)

Reissig A, Kroegel C. Transthoracic sonography of diffuse parenchymal lung disease: the role of comet tail artifacts. J Ultrasound Med. 2003 Feb;22(2):173-80. doi: 10.7863/jum.2003.22.2.173.

Reference Type BACKGROUND
PMID: 12562122 (View on PubMed)

Volpicelli G, Cardinale L, Garofalo G, Veltri A. Usefulness of lung ultrasound in the bedside distinction between pulmonary edema and exacerbation of COPD. Emerg Radiol. 2008 May;15(3):145-51. doi: 10.1007/s10140-008-0701-x. Epub 2008 Jan 31.

Reference Type BACKGROUND
PMID: 18236088 (View on PubMed)

Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

Reference Type BACKGROUND
PMID: 16984837 (View on PubMed)

Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.

Reference Type BACKGROUND
PMID: 15888847 (View on PubMed)

Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.

Reference Type BACKGROUND
PMID: 9372688 (View on PubMed)

Liteplo AS, Marill KA, Villen T, Miller RM, Murray AF, Croft PE, Capp R, Noble VE. Emergency thoracic ultrasound in the differentiation of the etiology of shortness of breath (ETUDES): sonographic B-lines and N-terminal pro-brain-type natriuretic peptide in diagnosing congestive heart failure. Acad Emerg Med. 2009 Mar;16(3):201-10. doi: 10.1111/j.1553-2712.2008.00347.x. Epub 2009 Jan 29.

Reference Type BACKGROUND
PMID: 19183402 (View on PubMed)

Pivetta E, Goffi A, Lupia E, Tizzani M, Porrino G, Ferreri E, Volpicelli G, Balzaretti P, Banderali A, Iacobucci A, Locatelli S, Casoli G, Stone MB, Maule MM, Baldi I, Merletti F, Cibinel GA, Baron P, Battista S, Buonafede G, Busso V, Conterno A, Del Rizzo P, Ferrera P, Pecetto PF, Moiraghi C, Morello F, Steri F, Ciccone G, Calasso C, Caserta MA, Civita M, Condo' C, D'Alessandro V, Del Colle S, Ferrero S, Griot G, Laurita E, Lazzero A, Lo Curto F, Michelazzo M, Nicosia V, Palmari N, Ricchiardi A, Rolfo A, Rostagno R, Bar F, Boero E, Frascisco M, Micossi I, Mussa A, Stefanone V, Agricola R, Cordero G, Corradi F, Runzo C, Soragna A, Sciullo D, Vercillo D, Allione A, Artana N, Corsini F, Dutto L, Lauria G, Morgillo T, Tartaglino B, Bergandi D, Cassetta I, Masera C, Garrone M, Ghiselli G, Ausiello L, Barutta L, Bernardi E, Bono A, Forno D, Lamorte A, Lison D, Lorenzati B, Maggio E, Masi I, Maggiorotto M, Novelli G, Panero F, Perotto M, Ravazzoli M, Saglio E, Soardo F, Tizzani A, Tizzani P, Tullio M, Ulla M, Romagnoli E; SIMEU Group for Lung Ultrasound in the Emergency Department in Piedmont. Lung Ultrasound-Implemented Diagnosis of Acute Decompensated Heart Failure in the ED: A SIMEU Multicenter Study. Chest. 2015 Jul;148(1):202-210. doi: 10.1378/chest.14-2608.

Reference Type DERIVED
PMID: 25654562 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEU-UTurin-001

Identifier Type: -

Identifier Source: org_study_id