Ultrasonography in the Emergency Department

NCT02550184 | Unknown DMC

• 1 other identifier: S-20150090
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim To investigate if the proportion of correctly diagnosed patients at 4 hours after arrival to the Emergency Department (ED) increases when patients are diagnosed with standard diagnostics and focused ultrasonography examination (f-US) compared to standard diagnostics alone. Methods The investigators are medical doctors who work in the ED and who use f-US as a diagnostic tool. The patients are those arriving to the ED with symptoms of difficulties of respiration. All patients receive a f-US but only in the intervention group these results will be unblinded to the treating physician once he has made his 1. presumptive diagnosis . A final presumptive diagnosis has to be made within 4 hours from the patient´s admittance to the ED. The correct diagnosis is assessed by a blinded audit of the medical journal. This project holds the potential to develop evidence-based optimization of early diagnostic accuracy.

Conditions

Acute Respiratory Failure; Chest Pain

Keywords

Patients with symptoms of acute respiratory problems

Outcome Measures

Primary Outcomes (1)

• The percentage of correctly diagnosed patients 4 hours after arrival in the emergency department.

  To measure and compare the percentage of correctly diagnosed patients at the time point '4 hours after admittance to the ED´ in between the intervention group and the control group.

  Measured at 4 hours after the patient has arrived to the Emergency Department

Study Arms (2)

Ultrasonography findings unblinded

EXPERIMENTAL

Intervention group: Patients in this group will receive a focused ultrasonography examination of the heart and the lungs which will be performed by the investigator. Intervention: The treating physician receives the results from the ultrasonographic examination (=unblinding of ultrasonography examination results).

Other: Focused ultrasonographic examination.

Ultrasonography findings blinded

ACTIVE COMPARATOR

Control group: Patients in this group will receive a focused ultrasonography examination of the heart and the lungs which will be performed by the investigator. Active Comparator: The ultrasonographic examination results will remain blinded for the treating physician.

Other: Focused ultrasonographic examination.

Interventions

Focused ultrasonographic examination. OTHER

Focused ultrasonographic examination of the lungs and the heart of patients who fulfill the inclusion criteria and who have given their informed and written consent for participation.

Ultrasonography findings blinded; Ultrasonography findings unblinded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All 4 parts have to be fulfilled.
• The patient is 18 years or more.
• The patient has arrived acutely to FAM.
• The patient presents with one or more of the following symptoms:
• Cough
• Dyspnea
• Chest pain
• Respiration frequency \> 20
• Peripheral saturation \< 95%
• Written informed consent from habile patient.

You may not qualify if:

• The patient is not capable of giving informed consent. .
• The US of the lungs or the heart has already been performed by others than the investigator in relation to the primary assessment.
• The Randomization and US cannot be performed within 4 hours from the patients admittance to the ED.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Related Publications (18)

• Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.

  PMID: 24998674 BACKGROUND

• Laursen CB, Sloth E, Lambrechtsen J, Lassen AT, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Focused sonography of the heart, lungs, and deep veins identifies missed life-threatening conditions in admitted patients with acute respiratory symptoms. Chest. 2013 Dec;144(6):1868-1875. doi: 10.1378/chest.13-0882.

  PMID: 23948720 BACKGROUND

• 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.

  PMID: 25654562 BACKGROUND

• Willenheimer RB, Israelsson BA, Cline CM, Erhardt LR. Simplified echocardiography in the diagnosis of heart failure. Scand Cardiovasc J. 1997;31(1):9-16. doi: 10.3109/14017439709058063.

  PMID: 9171143 BACKGROUND

• Zanobetti M, Poggioni C, Pini R. Can chest ultrasonography replace standard chest radiography for evaluation of acute dyspnea in the ED? Chest. 2011 May;139(5):1140-1147. doi: 10.1378/chest.10-0435. Epub 2010 Oct 14.

  PMID: 20947649 BACKGROUND

• 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.

  PMID: 18403664 BACKGROUND

• Parlamento S, Copetti R, Di Bartolomeo S. Evaluation of lung ultrasound for the diagnosis of pneumonia in the ED. Am J Emerg Med. 2009 May;27(4):379-84. doi: 10.1016/j.ajem.2008.03.009.

  PMID: 19555605 BACKGROUND

• 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.

  PMID: 16984837 BACKGROUND

• Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochive A, Pesce M, Evangelista A. Deep impact of ultrasound in the intensive care unit: the "ICU-sound" protocol. Anesthesiology. 2012 Oct;117(4):801-9. doi: 10.1097/ALN.0b013e318264c621.

  PMID: 22990179 BACKGROUND

• Arntfield RT, Millington SJ. Point of care cardiac ultrasound applications in the emergency department and intensive care unit--a review. Curr Cardiol Rev. 2012 May;8(2):98-108. doi: 10.2174/157340312801784952.

  PMID: 22894759 BACKGROUND

• Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.

  PMID: 23711341 BACKGROUND

• 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.

  PMID: 22392031 BACKGROUND

• Ferrada P, Anand RJ, Whelan J, Aboutanos MA, Duane T, Malhotra A, Ivatury R. Limited transthoracic echocardiogram: so easy any trauma attending can do it. J Trauma. 2011 Nov;71(5):1327-31; discussion 1331-2. doi: 10.1097/TA.0b013e3182318574.

  PMID: 22071932 BACKGROUND

• Manasia AR, Nagaraj HM, Kodali RB, Croft LB, Oropello JM, Kohli-Seth R, Leibowitz AB, DelGiudice R, Hufanda JF, Benjamin E, Goldman ME. Feasibility and potential clinical utility of goal-directed transthoracic echocardiography performed by noncardiologist intensivists using a small hand-carried device (SonoHeart) in critically ill patients. J Cardiothorac Vasc Anesth. 2005 Apr;19(2):155-9. doi: 10.1053/j.jvca.2005.01.023.

  PMID: 15868520 BACKGROUND

• Chalumeau-Lemoine L, Baudel JL, Das V, Arrive L, Noblinski B, Guidet B, Offenstadt G, Maury E. Results of short-term training of naive physicians in focused general ultrasonography in an intensive-care unit. Intensive Care Med. 2009 Oct;35(10):1767-71. doi: 10.1007/s00134-009-1531-3. Epub 2009 Jun 16.

  PMID: 19529914 BACKGROUND

• Jensen MB, Sloth E. [Transthoracic ultrasound: a necessary standard within intensive, acute and pre-hospital medicine]. Ugeskr Laeger. 2006 Dec 11;168(50):4393-6. Danish.

  PMID: 17217863 BACKGROUND

• Riishede M, Lassen AT, Baatrup G, Pietersen PI, Jacobsen N, Jeschke KN, Laursen CB. Point-of-care ultrasound of the heart and lungs in patients with respiratory failure: a pragmatic randomized controlled multicenter trial. Scand J Trauma Resusc Emerg Med. 2021 Apr 26;29(1):60. doi: 10.1186/s13049-021-00872-8.

  PMID: 33902667 DERIVED

• Riishede M, Laursen CB, Teglbjaerg LS, Lassen AT, Baatrup G. Focused ultrasound examination of the chest on patients admitted with acute signs of respiratory problems: a study protocol for a pragmatic randomised controlled multicentre trial. BMJ Open. 2016 Oct 14;6(10):e012367. doi: 10.1136/bmjopen-2016-012367.

  PMID: 27742624 DERIVED

Related Links

• Providers of the data base used for this project. Research Electronic Data Capture.
• Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gunnar Baatrup, Professor

  Department of Surgical Research. Department A, Odense University Hospital - Svendborg. Denmark.

  STUDY DIRECTOR

Central Study Contacts

Minna Riishede, Ph.D. stud

CONTACT

004540810583; Minna.Riishede@rsyd.dk

Christian B. Laursen, MD, PH.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d.-student, MD

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 15, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 28, 2015

Record last verified: 2015-10