Description: AIRPORT and ELITE trials for EUPHOREA AIRPORT-trial: The AIRPORT-trial is a prospective clinical observational study in 21 key international physician manned Helicopter Emergency Medical Services; to implement, validate and revise a novel Utstein-style template for uniform reporting of data from prehospital advanced airway management (1). The trial is conducted through the EUPHOREA research network, and funded by The Norwegian Air Ambulance Foundation. Project management: PhD candidate: Geir Arne Sunde, MD (Project manager) Ass. Prof Stephen Sollid, MD, PhD (Project main supervisor) Professor David Lockey, MD, PhD Ass. Prof Jon-Kenneth Heltne, MD, PhD Contact: Geir Arne Sunde, Email: geir.arne.sunde@norskluftambulanse.no Background for AIRPORT Advanced airway management and ventilatory control is generally regarded as vital in the management of seriously ill or injured patients (2, 3), and can be critical interventions in patients with out-of-hospital emergencies. However, interventions like tracheal intubation (TI) suffer from lack of clear evidence of a beneficial effect (1, 4, 5). Despite the publication of numerous airway management studies, inconsistent and imprecise reporting of data across heterogenous patient populations and EMS systems persists, and the questions of how, and by whom, prehospital advanced airway management should be performed remains disputed (4). The recognition of tracheal intubation as a “complex intervention” marks the need for an international standard for documenting and reporting of prehospital intubations in severely injured or ill patients, alongside a standardization of research data collection to eliminate confounding factors (4, 6, 7). An Utstein-style template for uniform reporting of data from prehospital advanced airway management has recently been developed by an international airway management expert group (1). The template proposes a core dataset constituting five major groups; “Core system variables”, “Core patient variables“, “Core post-intervention variables”, “Fixed system variables” and “Optional data variables”. To our knowledge, uniform standards for data reporting have never been implemented for prehospital advanced airway management across international physician manned EMS services and patient populations. Confidential Page 1 2/9/2016 Implementing and validating the novel Utstein-style template for prehospital airway management, may result in a high quality dataset and generate the opportunity for research cooperation and comparison of airway management practice between EMS systems, contributing new knowledge in this field (1, 4). The AIRPORT trial aims to describe the characteristics and outcome of advanced prehospital airway management from international Helicopter Emergency Medical Services that provide the full range of advanced emergency airway management. Status for the AIRPORT-trial per August 2013 AIRPORT was planned and ethically approved in 2011, then executed as a prospective clinical observational study during 2012 and spring of 2013. We enlisted 21 key international physician manned Helicopter Emergency Medical Services in 6 countries (UK, Australia, Hungary, Finland, Switzerland and Norway), and collected data according to the template for uniform reporting of data over a 12 month study period. Data sampling was completed on 15 March 2013, and the AIRPORT trial has included 2335 critically ill or injured patients, all receiving advanced prehospital airway management from physician manned HEMS. The project is now entering into the analysis stage, with publication of the first paper planned for late 2013. The trial is registered in Clinicaltrials.gov: NCT01502111. Participating centers in AIRPORT: HEMS-Base Main coordinators 1. Norway (7 bases) Geir Arne Sunde / Stephen Sollid 2. UK (2 bases) David Lockey / Richard Lyon 3. Australia (1 base) Brian Burns 4. Finland (3 bases) Helena Jäntti / Jouni Kurola 5. Hungary (7 bases) Akos Soti / Temesvári Péter 6. Switzerland (1 base) Falko Harm / Mathias Zuercher ELITE-trial: The ELITE trial is a prospective randomized controlled trial (RCT) in physician manned Emergency Medical Services to compare competent EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) < 9 and short ambulance transport times (< 20 min) to hospital. The trial is conducted through the EUPHOREA research network, and funded by The Norwegian Air Ambulance Foundation. Project management: PhD candidate: Geir Arne Sunde, MD (Project manager) PhD candidate: Espen Fevang, MD Ass. Prof Stephen Sollid, MD, PhD (Project main supervisor) Confidential Page 2 2/9/2016 Professor David Lockey, MD, PhD Professor Hans Morten Lossius, MD, PhD Ass. Prof Jon-Kenneth Heltne, MD, PhD Ass. Prof Jo Røislien, PhD Contact: Geir Arne Sunde, Email: geir.arne.sunde@norskluftambulanse.no Background for ELITE Advanced airway management and ventilatory control is generally regarded as vital in the management of seriously ill or injured patients, and can be critical interventions in patients with out-of-hospital emergencies (2, 3). However, prehospital interventions like endotracheal intubation (ETI) suffer from lack of clear evidence of a beneficial effect (1, 4, 5, 8-10). While some evidence indicate that early ETI is associated with increased mortality and worsened outcome, other studies maintain the benefits of prehospital intubation, e.g. in patients with severe head trauma, and the evidence still remains conflicting (9, 11-13). A study by Sollid et al demonstrated a probability as high as 29% of patients arriving in the hospital without ETI, despite a prehospital indication, and despite being treated by physician manned EMS services capable of delivering competent drugassisted airway interventions (14). A recent prospective randomized controlled trial on patients with severe traumatic brain injury, comparing early intubation by paramedics to late intubation by emergency department physicians, showed no differences in survival to hospital discharge (15). Comparably, both groups had similar admission vital signs and similar arterial blood gas values. Adversely, the study also showed higher prehospital cardiac arrest rates, higher prehospital missed intubation rates, longer on-scene times and higher IV-fluid rates in the early intubation group. The reported incidence of unanticipated difficult endotracheal intubation is much higher in patients served by prehospital EMS services than in patients due for in-hospital general anesthesia, and field intubation is associated with a higher rate of complications compared to in-hospital intubation (8, 16-19). When optimally performed by competent anesthesia trained providers, including standardization of pharmacological procedure for intubation and difficult airway management strategy, the incidence of unanticipated difficult prehospital or emergency intubations are still as high as 6 to 26,9 % (20-22). Provider competence and experience can be a major determinant in the performance of intubation, both inhospital, like the emergency department, and in the prehospital field (10, 17, 23, 24). To obtain a high degree of proficiency in advanced airway management skills, and to be able to maintain these skills and perform with a high probability of success under difficult operating conditions, can be challenging (25, 26). As the Scandinavian Society for Anaesthesiology and Intensive Care Medicine´s task force on prehospital airway management stated: “…even for maximally skilled personnel, it should always be considered whether intubation attempts Confidential Page 3 2/9/2016 should be performed prehospitally or be postponed till more advanced in-hospital techniques are available. The clinical situation as well as the distance from the hospital will decide the correct treatment in a given case” (27). A recent Cochrane review on emergency intubation suggested that there is insufficient high quality data available to comment on the efficacy of emergency endotracheal intubation (ETI) (28). Other studies also endorse further prospective randomized trials looking at prehospital advanced airway management (5, 29, 30). Very few comparable studies have been done in physician manned EMS services, and no prospective randomized controlled trials have been performed comparing endotracheal intubation to bag-mask-ventilation in patients with GCS < 9 and short transport times to hospital. Status for the ELITE trial per August 2013 The ELITE trial is planned as a prospective randomized controlled trial in several international physician manned helicopter emergency medical systems. The trial protocol was approved by the Regional Ethics Committee in Norway in autumn of 2012, and ethical applications are currently being sought in other participating countries. We are now in the process of recruiting national and international centers for participation, and plan to start ELITE in the first participating centers within the next few months. The trial is registered in Clinicaltrials.gov: NCT01730001 References 1. Sollid SJ, Lockey D, Lossius HM. A consensus-based template for uniform reporting of data from prehospital advanced airway management. Scand J Trauma Resusc Emerg Med. 2009;17:58. PubMed PMID: 19925688. Pubmed Central PMCID: 2785748. Epub 2009/11/21. eng. 2. Rotondo MF, McGonigal MD, Schwab CW, Kauder DR, Hanson CW. Urgent paralysis and intubation of trauma patients: is it safe? The Journal of trauma. 1993 Feb;34(2):242-6. PubMed PMID: 8459464. Epub 1993/02/01. eng. 3. Nolan JP, Deakin CD, Soar J, Bottiger BW, Smith G. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. PubMed PMID: 16321716. Epub 2005/12/03. eng. 4. Lossius HM, Sollid SJ, Rehn M, Lockey DJ. Revisiting the value of prehospital tracheal intubation: an all time systematic literature review extracting the Utstein airway core variables. Crit Care. 2011 Jan 18;15(1):R26. PubMed PMID: 21244667. Epub 2011/01/20. Eng. 5. Wirtz DD, Ortiz C, Newman DH, Zhitomirsky I. Unrecognized misplacement of endotracheal tubes by ground prehospital providers. Prehosp Emerg Care. 2007 Apr-Jun;11(2):213-8. PubMed PMID: 17454811. Epub 2007/04/25. eng. 6. Wang HE, Kupas DF, Greenwood MJ, Pinchalk ME, Mullins T, Gluckman W, et al. An algorithmic approach to prehospital airway management. Prehosp Emerg Care. 2005 Apr-Jun;9(2):145-55. PubMed PMID: 16036838. Epub 2005/07/23. eng. Confidential Page 4 2/9/2016 7. Davis D. The need for standardized data reporting for prehospital airway management. Critical Care. 2011 14 mars 2011;2011, 15:133.(15):133. 8. Hussmann B, Lefering R, Waydhas C, Ruchholtz S, Wafaisade A, Kauther MD, et al. Prehospital intubation of the moderately injured patient: a cause of morbidity? A matched-pairs analysis of 1,200 patients from the DGU Trauma Registry. Critical Care. 2011 Oct 10;15(5):R207. PubMed PMID: 21914175. Epub 2011/09/15. eng. 9. von Elm E, Schoettker P, Henzi I, Osterwalder J, Walder B. Prehospital tracheal intubation in patients with traumatic brain injury: systematic review of current evidence. British journal of anaesthesia. 2009 Sep;103(3):371-86. PubMed PMID: 19648153. Epub 2009/08/04. eng. 10. Yeh DD, Velmahos GC. Prehospital intubation for traumatic brain injury: do it correctly, or not at all. ANZ J Surg. 2012 Jul;82(7-8):484-5. PubMed PMID: 22863220. Epub 2012/08/07. eng. 11. Davis DP, Hoyt DB, Ochs M, Fortlage D, Holbrook T, Marshall LK, et al. The effect of paramedic rapid sequence intubation on outcome in patients with severe traumatic brain injury. The Journal of trauma. 2003 Mar;54(3):444-53. PubMed PMID: 12634522. Epub 2003/03/14. eng. 12. Winchell RJ, Hoyt DB. Endotracheal intubation in the field improves survival in patients with severe head injury. Trauma Research and Education Foundation of San Diego. Archives of surgery. 1997 Jun;132(6):592-7. PubMed PMID: 9197850. Epub 1997/06/01. eng. 13. Murray JA, Demetriades D, Berne TV, Stratton SJ, Cryer HG, Bongard F, et al. Prehospital intubation in patients with severe head injury. The Journal of trauma. 2000 Dec;49(6):1065-70. PubMed PMID: 11130490. Epub 2000/12/29. eng. 14. Sollid SJ, Lossius HM, Nakstad AR, Aven T, Soreide E. Risk assessment of prehospital trauma airway management by anaesthesiologists using the predictive Bayesian approach. Scandinavian journal of trauma, resuscitation and emergency medicine. 2010;18:22. PubMed PMID: 20409306. Pubmed Central PMCID: 2873366. Epub 2010/04/23. eng. 15. Bernard SA, Nguyen V, Cameron P, Masci K, Fitzgerald M, Cooper DJ, et al. Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial. Ann Surg. 2010 Dec;252(6):959-65. PubMed PMID: 21107105. Epub 2010/11/26. eng. 16. Karch SB, Lewis T, Young S, Hales D, Ho CH. Field intubation of trauma patients: complications, indications, and outcomes. The American journal of emergency medicine. 1996 Nov;14(7):617-9. PubMed PMID: 8906755. Epub 1996/11/01. eng. 17. Combes X, Jabre P, Jbeili C, Leroux B, Bastuji-Garin S, Margenet A, et al. Prehospital standardization of medical airway management: incidence and risk factors of difficult airway. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2006 Aug;13(8):828-34. PubMed PMID: 16807397. Epub 2006/06/30. eng. 18. Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. PubMed PMID: 8055603. Epub 1994/05/01. eng. Confidential Page 5 2/9/2016 19. Gunning M, O'Loughlin E, Fletcher M, Crilly J, Hooper M, Ellis DY. Emergency intubation: a prospective multicentre descriptive audit in an Australian helicopter emergency medical service. Emergency medicine journal : EMJ. 2009 Jan;26(1):65-9. PubMed PMID: 19104110. Epub 2008/12/24. eng. 20. Combes X, Jabre P, Jbeili C, Leroux B, Bastuji-Garin S, Margenet A, et al. Prehospital standardization of medical airway management: incidence and risk factors of difficult airway. Acad Emerg Med. 2006 Aug;13(8):828-34. PubMed PMID: 16807397. Epub 2006/06/30. eng. 21. Combes X, Jabre P, Margenet A, Merle JC, Leroux B, Dru M, et al. Unanticipated difficult airway management in the prehospital emergency setting: prospective validation of an algorithm. Anesthesiology. 2011 Jan;114(1):105-10. PubMed PMID: 21169803. Epub 2010/12/21. eng. 22. Adnet F, Cydulka RK, Lapandry C. Emergency tracheal intubation of patients lying supine on the ground: influence of operator body position. Can J Anaesth. 1998 Mar;45(3):266-9. PubMed PMID: 9579267. Epub 1998/05/14. eng. 23. Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the United States. Resuscitation. 2011 Apr;82(4):378-85. PubMed PMID: 21288624. Epub 2011/02/04. eng. 24. Schmidt UH, Kumwilaisak K, Bittner E, George E, Hess D. Effects of supervision by attending anesthesiologists on complications of emergency tracheal intubation. Anesthesiology. 2008 Dec;109(6):973-7. PubMed PMID: 19034093. Epub 2008/11/27. eng. 25. Genzwuerker HV. Prehospital airway management: the patient needs oxygen! Scand J Trauma Resusc Emerg Med. 2008;16:3. PubMed PMID: 18957065. Pubmed Central PMCID: 2556638. Epub 2008/10/30. eng. 26. Sollid SJ, Heltne JK, Soreide E, Lossius HM. Prehospital advanced airway management by anaesthesiologists: is there still room for improvement? Scand J Trauma Resusc Emerg Med. 2008;16:2. PubMed PMID: 18957064. Pubmed Central PMCID: 2556637. Epub 2008/10/30. eng. 27. Berlac P, Hyldmo PK, Kongstad P, Kurola J, Nakstad AR, Sandberg M. Prehospital airway management: guidelines from a task force from the Scandinavian Society for Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2008 Aug;52(7):897-907. PubMed PMID: 18702752. Epub 2008/08/16. eng. 28. Lecky F, Bryden D, Little R, Tong N, Moulton C. Emergency intubation for acutely ill and injured patients. Cochrane Database Syst Rev. 2008 (2):CD001429. PubMed PMID: 18425873. Epub 2008/04/22. eng. 29. Fevang E, Lockey D, Thompson J, Lossius HM. The top five research priorities in physician-provided prehospital critical care: a consensus report from a European research collaboration. Scandinavian journal of trauma, resuscitation and emergency medicine. 2011;19:57. PubMed PMID: 21996444. Pubmed Central PMCID: 3204240. Epub 2011/10/15. eng. 30. Bochicchio GV, Ilahi O, Joshi M, Bochicchio K, Scalea TM. Endotracheal intubation in the field does not improve outcome in trauma patients who present without an acutely lethal traumatic brain injury. The Journal of trauma. 2003 Feb;54(2):307-11. PubMed PMID: 12579056. Epub 2003/02/13. eng. Confidential Page 6 2/9/2016