Respiratory Failure Clinical Trial
Official title:
Training Thoracic Ultrasound Skills: a Multicentre, Blinded, Randomized Controlled Trial of Simulation-based Training Versus Training on Healthy Figurants
The use of thoracic ultrasound has expanded widely within the las couple of years, and
several studies have proved a high diagnostic accuracy for many of the most common causes of
respiratory failure and dyspnoea.
The ultrasound scan is a bed-side, and dynamic examination, which demands sufficient
theoretical and practical knowledge and competence by the operator, but so far, no studies
have explored the effect of simulation-based training for gaining adequate competence
compared to traditional hands-on training on healthy figurants.
The aim of this study is to examine whether TUS training on a simulator is superior to
training on healthy figurants. Secondly, to examine whether the choice of hands-on training
has an effect on the number of examinations performed by the trainees from baseline to 4
months follow-up.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Physicians with no previous experience in thoracic ultrasound Exclusion Criteria: - Physicians with relation to the trial or study - Physicians with previous experience in thoracic ultrasound - Physicians who do not provide written consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Regional Center for Technical Simulation | Odense C |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
Adhikari S, Zeger W, Wadman M, Walker R, Lomneth C. Assessment of a human cadaver model for training emergency medicine residents in the ultrasound diagnosis of pneumothorax. Biomed Res Int. 2014;2014:724050. doi: 10.1155/2014/724050. Epub 2014 Mar 25. — View Citation
Al Deeb M, Barbic S, Featherstone R, Dankoff J, Barbic D. Point-of-care ultrasonography for the diagnosis of acute cardiogenic pulmonary edema in patients presenting with acute dyspnea: a systematic review and meta-analysis. Acad Emerg Med. 2014 Aug;21(8):843-52. doi: 10.1111/acem.12435. Review. — View Citation
Breitkreutz R, Dutiné M, Scheiermann P, Hempel D, Kujumdshiev S, Ackermann H, Seeger FH, Seibel A, Walcher F, Hirche TO. Thorax, trachea, and lung ultrasonography in emergency and critical care medicine: assessment of an objective structured training concept. Emerg Med Int. 2013;2013:312758. doi: 10.1155/2013/312758. Epub 2013 Nov 27. — View Citation
Dinh VA, Giri PC, Rathinavel I, Nguyen E, Hecht D, Dorotta I, Nguyen HB, Chrissian AA. Impact of a 2-Day Critical Care Ultrasound Course during Fellowship Training: A Pilot Study. Crit Care Res Pract. 2015;2015:675041. doi: 10.1155/2015/675041. Epub 2015 Aug 5. — View Citation
Greenstein YY, Littauer R, Narasimhan M, Mayo PH, Koenig SJ. Effectiveness of a Critical Care Ultrasonography Course. Chest. 2017 Jan;151(1):34-40. doi: 10.1016/j.chest.2016.08.1465. Epub 2016 Sep 16. — View Citation
Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. — View Citation
Heiberg J, Hansen LS, Wemmelund K, Sørensen AH, Ilkjaer C, Cloete E, Nolte D, Roodt F, Dyer R, Swanevelder J, Sloth E. Point-of-Care Clinical Ultrasound for Medical Students. Ultrasound Int Open. 2015 Nov;1(2):E58-66. doi: 10.1055/s-0035-1565173. Epub 2015 Nov 6. — View Citation
Jensen K, Bjerrum F, Hansen HJ, Petersen RH, Pedersen JH, Konge L. A new possibility in thoracoscopic virtual reality simulation training: development and testing of a novel virtual reality simulator for video-assisted thoracoscopic surgery lobectomy. Interact Cardiovasc Thorac Surg. 2015 Oct;21(4):420-6. doi: 10.1093/icvts/ivv183. Epub 2015 Jul 10. — View Citation
Lee KH, Ahn JH, Jung RB, Hong CK, Shin TY, Kim YS, Ha YR. Evaluation of a novel simulation method of teaching B-lines: hand ultrasound with a wet foam dressing material. Clin Exp Emerg Med. 2015 Jun 30;2(2):89-94. eCollection 2015 Jun. — View Citation
Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096. Review. — View Citation
Madsen ME, Konge L, Nørgaard LN, Tabor A, Ringsted C, Klemmensen AK, Ottesen B, Tolsgaard MG. Assessment of performance measures and learning curves for use of a virtual-reality ultrasound simulator in transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2014 Dec;44(6):693-9. doi: 10.1002/uog.13400. Epub 2014 Nov 9. — View Citation
Maul H, Scharf A, Baier P, Wüstemann M, Günter HH, Gebauer G, Sohn C. Ultrasound simulators: experience with the SonoTrainer and comparative review of other training systems. Ultrasound Obstet Gynecol. 2004 Oct;24(5):581-5. — View Citation
McGaghie WC, Issenberg SB, Petrusa ER, Scalese RJ. A critical review of simulation-based medical education research: 2003-2009. Med Educ. 2010 Jan;44(1):50-63. doi: 10.1111/j.1365-2923.2009.03547.x. Review. — View Citation
Mendiratta-Lala M, Williams T, de Quadros N, Bonnett J, Mendiratta V. The use of a simulation center to improve resident proficiency in performing ultrasound-guided procedures. Acad Radiol. 2010 Apr;17(4):535-40. doi: 10.1016/j.acra.2009.11.010. Epub 2010 Jan 25. — View Citation
Minimum training requirements for the practice of Medical Ultrasound in Europe. Ultraschall Med. 2010 Aug;31(4):426-7. doi: 10.1055/s-0030-1263214. Epub 2010 Aug 19. — View Citation
Oveland NP, Lossius HM, Aagaard R, Connolly J, Sloth E, Knudsen L. Animal laboratory training improves lung ultrasound proficiency and speed. J Emerg Med. 2013 Sep;45(3):e71-8. doi: 10.1016/j.jemermed.2013.03.029. Epub 2013 May 15. — View Citation
Pedersen P, Palm H, Ringsted C, Konge L. Virtual-reality simulation to assess performance in hip fracture surgery. Acta Orthop. 2014 Aug;85(4):403-7. doi: 10.3109/17453674.2014.917502. Epub 2014 Apr 30. — View Citation
Reznek M, Harter P, Krummel T. Virtual reality and simulation: training the future emergency physician. Acad Emerg Med. 2002 Jan;9(1):78-87. Review. — View Citation
Sanchez-de-Toledo J, Renter-Valdovinos L, Esteves M, Fonseca C, Villaverde I, Rosal M. Teaching Chest Ultrasound in an Experimental Porcine Model. Pediatr Emerg Care. 2016 Nov;32(11):768-772. — View Citation
Skaarup SH, Laursen CB, Bjerrum AS, Hilberg O. Objective and Structured Assessment of Lung Ultrasound Competence. A Multispecialty Delphi Consensus and Construct Validity Study. Ann Am Thorac Soc. 2017 Apr;14(4):555-560. doi: 10.1513/AnnalsATS.201611-894OC. — View Citation
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. Review. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in LUS-OSAUS score | Difference in assessment score (Lung Ultrasound Objective Structured Assessment of Ultrasound Skills score) between the three groups (total score). The scale comprises 17 items with a score from 1-5 in each. Minimum 17, maximum 85, meaning that a score of 85 point is the best possible ultrasound examination. |
3 months (on the day of practical assessment, maximum 3 months after inclusion) | |
Secondary | Time used for hands-on training | Time used for hands-on training between the two interventional groups (minutes) | 3 months (on the day of practical assessment, maximum 3 months after inclusion) | |
Secondary | Number of performed examinations | Number of performed examinations from baseline to 4 months follow up | 4 months after day of practical assessment |
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