Außerklinische Notfallmedizin in Deutschland, Österreich und der Schweiz
- 938 Downloads
- 3 Citations
Zusammenfassung
Hintergrund
Lediglich auf Basis randomisierter, prospektiver klinischer Studien kann die Therapie von Patienten mit lebensgefährlichen Verletzungen oder Erkrankungen verbessert werden. Beobachtungen aus England und Nordamerika zeigten allerdings einen deutlichen Rückgang solcher Studien. Untersucht wurde der Beitrag deutschsprachiger Länder an Publikationen von klinischen randomisierten, prospektiven Studien in der Notfallmedizin der letzten 22 Jahre.
Methoden
Für den Zeitraum 01.01.1990 bis 31.12.2012 wurde eine Internetrecherche in der Onlinedatenbank Medline mit den (Tracer-)Diagnosen „Herz-Kreislauf-Stillstand“, „kardiopulmonale Reanimation“, „Polytrauma“, „hämorrhagischer Schock“, „Schädel-Hirn-Trauma“, „Schlaganfall“ oder „Herzinfarkt“ durchgeführt. Nur prospektive, randomisierte und kontrollierte Arbeiten aus Deutschland, Österreich und der Schweiz wurden aufgenommen.
Ergebnisse
Von 474 Studien aus deutschsprachigen Ländern erfüllten 25 (5,3 %) die Einschlusskriterien. Von 1990 bis Ende 2012 wurde gleichbleibend ca. eine prospektive, randomisierte, kontrollierte Studie pro Jahr aus Deutschland, Österreich und der Schweiz zu den genannten Diagnosen publiziert. Die Patientenzahl betrug im Median bei 159 (Minimum 16, Maximum 1219). Die meisten Studien (80 %) hatten ihren Ursprung in Deutschland und wurden überwiegend im Fachbereich der Anästhesiologie (68 %) durchgeführt. In 68 % der Studien war der „Herz-Kreislauf-Stillstand“ das untersuchte Thema. Etwa die Hälfte der Studien bekam finanzielle Unterstützung von der Industrie.
Schlussfolgerung
In dieser retrospektiven Studie konnte keine eindeutige Zu- oder Abnahme an prospektiven, randomisierten, kontrollierten Studien in der deutschsprachigen Notfallmedizin der letzten 22 Jahre festgestellt werden, obwohl insgesamt die Zahl an notfallmedizinischen Studien zugenommen hat. Pro Jahr kommt durchschnittlich nur eine prospektive, randomisierte, klinische Studie mit notfallmedizinischen (Tracer-)Kerndiagnosen aus Deutschland, Österreich oder der Schweiz.
Schlüsselwörter
Herz-Kreislauf-Stillstand Kardiopulmonale Reanimation Trauma Schlaganfall Literatur als ThemaOut-of-hospital emergency medicine in Germany, Austria and Switzerland
Abstract
Background
Only randomized clinical trials can improve the outcome of life-threatening injuries or diseases but observations from England and North America suggest that the number of such randomized clinical trials is decreasing. In this study contributions from German speaking countries with regards to randomized clinical trials in emergency medicine over the last 22 years were investigated.
Methods
The Medline database was searched from January 1990 to December 2012 for prospective randomized clinical trials in the prehospital setting using the criteria “cardiac arrest”, “cardiopulmonary resuscitation”, “multiple trauma”, “hemorrhagic shock”, “head trauma”, “stroke” as well as myocardial infarction and emergency medical service. Only studies originating from Germany, Austria or Switzerland were included.
Results
A total of 474 studies were found and 25 studies (5.3 %) fulfilled the inclusion criteria. In the last 22 years German speaking countries have published approximately one prospective, randomized, clinical trial per year on prehospital emergency medicine. The median number of patients included in the trials was 159 (minimum 16, maximum 1,219). Most (80 %) studies originated from Germany and most (64 %) studies were conducted by anesthesiology departments. Cardiac arrest was the most frequent subject of the investigated studies. Approximately 50 % of the studies had financial support from industrial companies.
Conclusion
A significant increase or decrease in the number of prospective randomized clinical trials in the out-of-hospital setting could not be found in German speaking countries despite the fact that the absolute numbers of studies had increased. Only about one prospective, randomized clinical trial with an emergency medicine core tracer diagnosis originated from Germany, Austria and Switzerland per year.
Keywords
Cardiac arrest Cardiopulmonary resuscitation Trauma Stroke Review literature as topicNotes
Einhaltung ethischer Richtlinien
Interessenkonflikt. J. Ausserer, T. Abt, K.H. Stadlbauer, P. Paal, J. Kreutziger, K.H. Lindner, V. Wenzel geben an, dass kein Interessenkonflikt besteht. Der Beitrag enthält keine Studien an Menschen oder Tieren.
Literatur
- 1.Arntz HR, Agrawal R, Richter H et al (2001) Phased chest and abdominal compression-decompression versus conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest. Circulation 104:768–772PubMedCrossRefGoogle Scholar
- 2.Aufderheide TP, Nichol G, Rea TD et al (2011) A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med 365:798–806PubMedCentralPubMedCrossRefGoogle Scholar
- 3.Baubin M, Sumann G, Rabl W et al (1999) Increased frequency of thorax injuries with ACD-CPR. Resuscitation 41:33–38PubMedCrossRefGoogle Scholar
- 4.Bender R, Breil M, Heister U et al (2007) Hypertonic saline during CPR: feasibility and safety of a new protocol of fluid management during resuscitation. Resuscitation 72:74–81PubMedCrossRefGoogle Scholar
- 5.Bickell WH, Wall MJ Jr, Pepe PE et al (1994) Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med 331:1105–1109PubMedCrossRefGoogle Scholar
- 6.Bohn A, Weber TP, Wecker S et al (2011) The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation 82:257–262PubMedCrossRefGoogle Scholar
- 7.Bottiger BW, Arntz HR, Chamberlain DA et al (2008) Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med 359:2651–2662PubMedCrossRefGoogle Scholar
- 8.Böttiger BW, Bauer H (2002) Studien in der Notfallmedizin. Design, Machbarkeit, Stichprobenumfang, Finanzierung. Notfall Rettungsmed 5:249–255CrossRefGoogle Scholar
- 9.Breil M, Krep H, Heister U et al (2012) Randomised study of hypertonic saline infusion during resuscitation from out-of-hospital cardiac arrest. Resuscitation 83:347–352PubMedCrossRefGoogle Scholar
- 10.Bulger EM, May S, Kerby JD et al (2011) Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg 253:431–441PubMedCentralPubMedCrossRefGoogle Scholar
- 11.Dussoix P, Reuille O, Verin V et al (2003) Time savings with prehospital thrombolysis in an urban area. Eur J Emerg Med 10:2–5PubMedCrossRefGoogle Scholar
- 12.EUR-Lex (1999) Verordnung (EG) Nr. 141/2000 des europäischen Parlaments und des Rates über Arzneimittel für seltene Leiden. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2000R0141:20090807:DE:PDFGoogle Scholar
- 13.Feneck RO, Natarajan N, Sebastian R, Naughton C (2008) Decline in research publications from the United Kingdom in anaesthesia journals from 1997 to 2006. Anaesthesia 63:270–275PubMedCrossRefGoogle Scholar
- 14.Gawande A (2004) Casualties of war – military care for the wounded from Iraq and Afghanistan. N Engl J Med 351:2471–2475PubMedCrossRefGoogle Scholar
- 15.Georgiou AP, Manara AR (2013) Role of therapeutic hypothermia in improving outcome after traumatic brain injury: a systematic review. Br J Anaesth 110:357–367PubMedCrossRefGoogle Scholar
- 16.Hanning CD, Rentowl P (2006) Harmful impact of EU clinical trials directive: trial of alerting drug in fibromyalgia has had to be abandoned. BMJ 332:666PubMedCrossRefGoogle Scholar
- 17.Hemminki A, Kellokumpu-Lehtinen PL (2006) Harmful impact of EU clinical trials directive. BMJ 332:501–502PubMedCrossRefGoogle Scholar
- 18.Jones CW, Handler L, Crowell KE et al (2013) Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 347:f6104PubMedCentralPubMedCrossRefGoogle Scholar
- 19.Jusline (2013) Arzneimittelgesetz Deutschland. http://www.jusline.de/index.php?cpid=f92f99b766343e040d46fcd6b03d3ee8&lawid=207&paid=41Google Scholar
- 20.Jusline (2013) Arzneimittelgesetz Österreich. http://www.jusline.at/43a.AMG.htmlGoogle Scholar
- 21.Kerner T, Ahlers O, Veit S et al (2003) DCL-Hb for trauma patients with severe hemorrhagic shock: the European „On-Scene“ multicenter study. Intensive Care Med 29:378–385PubMedGoogle Scholar
- 22.Kreutziger J, Wenzel V (2009) Overcoming frustration about neutral clinical studies in cardiopulmonary resuscitation. Resuscitation 80:723–725PubMedCrossRefGoogle Scholar
- 23.Lienhart HG, Wenzel V, Braun J et al (2007) Vasopressin for therapy of persistent traumatic hemorrhagic shock: the VITRIS.at study. Anaesthesist 56:145–148, 150PubMedCrossRefGoogle Scholar
- 24.Lindner KH, Ahnefeld FW, Prengel AW (1991) Comparison of standard and high-dose adrenaline in the resuscitation of asystole and electromechanical dissociation. Acta Anaesthesiol Scand 35:253–256PubMedCrossRefGoogle Scholar
- 25.Lindner KH, Dirks B, Strohmenger HU et al (1997) Randomised comparison of epinephrine and vasopressin in patients with out-of-hospital ventricular fibrillation. Lancet 349:535–537PubMedCrossRefGoogle Scholar
- 26.Luiz T, Ellinger K, Denz C (1996) Active compression-decompression cardiopulmonary resuscitation does not improve survival in patients with prehospital cardiac arrest in a physician-manned emergency medical system. J Cardiothorac Vasc Anesth 10:178–186PubMedCrossRefGoogle Scholar
- 27.Mauer D, Schneider T, Dick W et al (1996) Active compression-decompression resuscitation: a prospective, randomized study in a two-tiered EMS system with physicians in the field. Resuscitation 33:125–134PubMedCrossRefGoogle Scholar
- 28.Mauer D, Schneider T, Elich D, Dick W (1998) Carbon dioxide levels during pre-hospital active compression--decompression versus standard cardiopulmonary resuscitation. Resuscitation 39:67–74PubMedCrossRefGoogle Scholar
- 29.Ornato JP, Becker LB, Weisfeldt ML, Wright BA (2010) Cardiac arrest and resuscitation: an opportunity to align research prioritization and public health need. Circulation 122:1876–1879PubMedCrossRefGoogle Scholar
- 30.Pagel PS, Hudetz JA (2013) A bibliometric analysis of geographic publication variations in the Journal of Cardiothoracic and Vascular Anesthesia from 1990 to 2011. J Cardiothorac Vasc Anesth 27:208–212PubMedCrossRefGoogle Scholar
- 31.Pels K, Schroder J, Witzenbichler B et al (2008) Prehospital versus periprocedural abciximab in ST-elevation myocardial infarction treated by percutaneous coronary intervention. Eur J Emerg Med 15:324–329PubMedCrossRefGoogle Scholar
- 32.Rabitsch W, Schellongowski P, Staudinger T et al (2003) Comparison of a conventional tracheal airway with the Combitube in an urban emergency medical services system run by physicians. Resuscitation 57:27–32PubMedCrossRefGoogle Scholar
- 33.ROC (2013) Resuscitation Outcome Consortium. https://www.wwctc.org/tiki/roc-backgroundGoogle Scholar
- 34.Schneider T, Martens PR, Paschen H et al (2000) Multicenter, randomized, controlled trial of 150–J biphasic shocks compared with 200– to 360–J monophasic shocks in the resuscitation of out-of-hospital cardiac arrest victims. Optimized Response to Cardiac Arrest (ORCA) Investigators. Circulation 102:1780–1787PubMedCrossRefGoogle Scholar
- 35.Schneider T, Mauer D, Diehl P et al (1994) Early defibrillation by emergency physicians or emergency medical technicians? A controlled, prospective multi-centre study. Resuscitation 27:197–206PubMedCrossRefGoogle Scholar
- 36.Schofer J, Buttner J, Geng G et al (1990) Prehospital thrombolysis in acute myocardial infarction. Am J Cardiol 66:1429–1433PubMedCrossRefGoogle Scholar
- 37.Steiner T, Hennes HJ, Kretz R, Hacke W (2000) Treatment of acute clinical stroke. Anaesthesist 49:2–8PubMedCrossRefGoogle Scholar
- 38.Thiele H, Eitel I, Meinberg C et al (2011) Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv 4:605–614PubMedCrossRefGoogle Scholar
- 39.Thiele H, Engelmann L, Elsner K et al (2005) Comparison of pre-hospital combination-fibrinolysis plus conventional care with pre-hospital combination-fibrinolysis plus facilitated percutaneous coronary intervention in acute myocardial infarction. Eur Heart J 26:1956–1963PubMedCrossRefGoogle Scholar
- 40.Clinical trial Register (2013). In: http://clinical.trials.gov/Google Scholar
- 41.Trimmel H, Kreutziger J, Fertsak G et al (2011) Use of the Airtraq laryngoscope for emergency intubation in the prehospital setting: a randomized control trial. Crit Care Med 39:489–493PubMedCrossRefGoogle Scholar
- 42.Walter S, Kostopoulos P, Haass A et al (2012) Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol 11:397–404PubMedCrossRefGoogle Scholar
- 43.Weber EJ, Callaham ML, Wears RL et al (1998) Unpublished research from a medical specialty meeting: why investigators fail to publish. JAMA 280:257–259PubMedCrossRefGoogle Scholar
- 44.Wenzel V, Krismer AC, Arntz HR et al (2004) A comparison of vasopressin and epinephrine for out-of-hospital cardiopulmonary resuscitation. N Engl J Med 350:105–113PubMedCrossRefGoogle Scholar
- 45.Wenzel V, Russo SG, Arntz HR et al (2010) Comments on the 2010 guidelines on cardiopulmonary resuscitation of the European Resuscitation Council. Anaesthesist 59:1105–1123PubMedCrossRefGoogle Scholar
- 46.Wolcke BB, Mauer DK, Schoefmann MF et al (2003) Comparison of standard cardiopulmonary resuscitation versus the combination of active compression-decompression cardiopulmonary resuscitation and an inspiratory impedance threshold device for out-of-hospital cardiac arrest. Circulation 108:2201–2205PubMedCrossRefGoogle Scholar
- 47.Zeymer U, Arntz HR, Mark B et al (2012) Efficacy and safety of a high loading dose of clopidogrel administered prehospitally to improve primary percutaneous coronary intervention in acute myocardial infarction: the randomized CIPAMI trial. Clin Res Cardiol 101:305–312PubMedCrossRefGoogle Scholar