Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea

NCT ID: NCT02105207

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-02-29

Brief Summary

For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.

Detailed Description

Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea.

Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology ("LUS-implemented" diagnosis). All patients will then undergo CXR.

In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available.

After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case.

Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "Positive" and "negative" results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.

Conditions

Dyspnea; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lung Ultrasound

In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography.

Group Type: EXPERIMENTAL

Lung Ultrasound

Intervention Type: OTHER

Lung ultrasound evaluation is performed after clinical assessment and before chest radiography

Chest Radiography

In Patients allocated to this arm chest radiography will be performed for the detection of indirect signs of pulmonary congestion/ADHF without ultrasound evaluation.

Group Type: EXPERIMENTAL

Chest Radiography

Intervention Type: OTHER

Chest Radiography is performed after clinical evaluation without using ultrasound assessment

Interventions

Lung Ultrasound

Lung ultrasound evaluation is performed after clinical assessment and before chest radiography

Intervention Type: OTHER

Chest Radiography

Chest Radiography is performed after clinical evaluation without using ultrasound assessment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• acute dyspnea as chief complaint
• presence of an emergency physician skilled in lung ultrasound at evaluation time

Exclusion Criteria

• mechanical ventilation ongoing at enrolment time
• dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Enrico Lupia, MD, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Lupia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

AOU Città della Salute e della Scienza di Torino

Turin, , Italy

Countries

Italy

References

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)

Niska R, Bhuiya F, Xu J. National Hospital Ambulatory Medical Care Survey: 2007 emergency department summary. Natl Health Stat Report. 2010 Aug 6;(26):1-31.

Reference Type: BACKGROUND

PMID: 20726217 (View on PubMed)

Peacock WF, Braunwald E, Abraham W, Albert N, Burnett J, Christenson R, Collins S, Diercks D, Fonarow G, Hollander J, Kellerman A, Gheorghiade M, Kirk D, Levy P, Maisel A, Massie BM, O'Connor C, Pang P, Shah M, Sopko G, Stevenson L, Storrow A, Teerlink J. National Heart, Lung, and Blood Institute working group on emergency department management of acute heart failure: research challenges and opportunities. J Am Coll Cardiol. 2010 Jul 27;56(5):343-51. doi: 10.1016/j.jacc.2010.03.051.

Reference Type: BACKGROUND

PMID: 20650354 (View on PubMed)

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)

Redfield MM. Heart failure--an epidemic of uncertain proportions. N Engl J Med. 2002 Oct 31;347(18):1442-4. doi: 10.1056/NEJMe020115. No abstract available.

Reference Type: BACKGROUND

PMID: 12409548 (View on PubMed)

McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.

Reference Type: BACKGROUND

PMID: 12135939 (View on PubMed)

McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

Reference Type: BACKGROUND

PMID: 22611136 (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)

Gillespie ND, McNeill G, Pringle T, Ogston S, Struthers AD, Pringle SD. Cross sectional study of contribution of clinical assessment and simple cardiac investigations to diagnosis of left ventricular systolic dysfunction in patients admitted with acute dyspnoea. BMJ. 1997 Mar 29;314(7085):936-40. doi: 10.1136/bmj.314.7085.936.

Reference Type: BACKGROUND

PMID: 9099117 (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)

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)

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)

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)

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

Reference Type: BACKGROUND

PMID: 22392031 (View on PubMed)

Noble VE, Murray AF, Capp R, Sylvia-Reardon MH, Steele DJR, Liteplo A. Ultrasound assessment for extravascular lung water in patients undergoing hemodialysis. Time course for resolution. Chest. 2009 Jun;135(6):1433-1439. doi: 10.1378/chest.08-1811. Epub 2009 Feb 2.

Reference Type: BACKGROUND

PMID: 19188552 (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)

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)

Trovato GM, Sperandeo M. Sounds, ultrasounds, and artifacts: which clinical role for lung imaging? Am J Respir Crit Care Med. 2013 Apr 1;187(7):780-1. doi: 10.1164/ajrccm.187.7.780. No abstract available.

Reference Type: BACKGROUND

PMID: 23540884 (View on PubMed)

Anderson KL, Jenq KY, Fields JM, Panebianco NL, Dean AJ. Diagnosing heart failure among acutely dyspneic patients with cardiac, inferior vena cava, and lung ultrasonography. Am J Emerg Med. 2013 Aug;31(8):1208-14. doi: 10.1016/j.ajem.2013.05.007. Epub 2013 Jun 13.

Reference Type: BACKGROUND

PMID: 23769272 (View on PubMed)

Maisel A. B-type natriuretic peptide levels: diagnostic and prognostic in congestive heart failure: what's next? Circulation. 2002 May 21;105(20):2328-31. doi: 10.1161/01.cir.0000019121.91548.c2. No abstract available.

Reference Type: BACKGROUND

PMID: 12021215 (View on PubMed)

Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.

Reference Type: BACKGROUND

PMID: 16293638 (View on PubMed)

Cibinel GA, Casoli G, Elia F, Padoan M, Pivetta E, Lupia E, Goffi A. Diagnostic accuracy and reproducibility of pleural and lung ultrasound in discriminating cardiogenic causes of acute dyspnea in the emergency department. Intern Emerg Med. 2012 Feb;7(1):65-70. doi: 10.1007/s11739-011-0709-1. Epub 2011 Oct 28.

Reference Type: BACKGROUND

PMID: 22033792 (View on PubMed)

Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J, Nowak RM, Aumont MC, Duc P, Hollander JE, Wu AH, McCullough PA, Maisel AS. Diagnostic value of B-Type natriuretic peptide and chest radiographic findings in patients with acute dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. doi: 10.1016/j.amjmed.2003.10.028.

Reference Type: BACKGROUND

PMID: 15006584 (View on PubMed)

Gargani L, Frassi F, Soldati G, Tesorio P, Gheorghiade M, Picano E. Ultrasound lung comets for the differential diagnosis of acute cardiogenic dyspnoea: a comparison with natriuretic peptides. Eur J Heart Fail. 2008 Jan;10(1):70-7. doi: 10.1016/j.ejheart.2007.10.009.

Reference Type: BACKGROUND

PMID: 18077210 (View on PubMed)

Garcia X, Simon P, Guyette FX, Ramani R, Alvarez R, Quintero J, Pinsky MR. Noninvasive assessment of acute dyspnea in the ED. Chest. 2013 Aug;144(2):610-615. doi: 10.1378/chest.12-1676.

Reference Type: BACKGROUND

PMID: 23471509 (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)

Eurlings LW, Sanders-van Wijk S, van Kimmenade R, Osinski A, van Helmond L, Vallinga M, Crijns HJ, van Dieijen-Visser MP, Brunner-La Rocca HP, Pinto YM. Multimarker strategy for short-term risk assessment in patients with dyspnea in the emergency department: the MARKED (Multi mARKer Emergency Dyspnea)-risk score. J Am Coll Cardiol. 2012 Oct 23;60(17):1668-77. doi: 10.1016/j.jacc.2012.06.040. Epub 2012 Sep 26.

Reference Type: BACKGROUND

PMID: 23021334 (View on PubMed)

Other Identifiers

iLUS-RCT

Identifier Type: -

Identifier Source: org_study_id