Impact of the Final Rule on the rate of clinical cardiac arrest research in the United States

Academic Emergency Medicine

Volumn 12, Issue 11, 2005, Pages 1091-1098

  Hiller, Katherine M ^a   Haukoos, Jason S ^b,c   Heard, Kennon ^c   Tashkin, Jonathan S ^d   Paradis, Norman A ^c  

^a UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^b DENVER HEALTH MEDICAL CENTER   (United States)

^c UNIVERSITY OF COLORADO   (United States)

^d Medical Center of Aurora   (United States)

Author keywords

Cardiac arrest; Clinical research; Emergency consent; Final Rule; Informed consent

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; COMPARATIVE STUDY; CONFERENCE PAPER; CONFIDENCE INTERVAL; EUROPEAN UNION; HEART ARREST; HUMAN; INFORMED CONSENT; MEDICAL LITERATURE; MEDLINE; PRIORITY JOURNAL; PUBLICATION; STATISTICAL SIGNIFICANCE; UNITED STATES;

DATA COLLECTION; EMERGENCY MEDICINE; EUROPEAN UNION; GUIDELINES; HEART ARREST; HUMANS; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIALS; RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 27144461994     PISSN: 10696563     EISSN: None     Source Type: Journal    
DOI: 10.1197/j.aem.2005.04.025     Document Type: Conference Paper

References (82)

1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Apr 18, 1979 U.S. Government Printing Office Washington, DC
2. Ellis GB. "Dear Colleague" letter: human subjects protection. OPRR Rep. 1993; Aug 12(93-3).
3. U.S. Department of Health and Human Services. Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Circumstances. In: 21 CFR 50; 45 CFR 46; 1996.
4. M.H. Biros Research without consent: current status, 2003 Ann Emerg Med 42 2003 550 564
5. T.A. Santora, V. Cowell, and S.Z. Trooskin Working through the public disclosure process mandated by use of 21 CFR 50.24 (Exception to Informed Consent): guidelines for success J Trauma 45 1998 907 913
6. M.S. Kremers, Dr Whisnant, L.S. Lowder, and L. Gregg Initial experience using the Food and Drug Administration guidelines for emergency research without consent Ann Emerg Med 33 1999 224 229
7. V.N. Mosesso Jr., L.H. Brown, and H.L. Greene Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience Resuscitation 61 2004 29 36
8. B.D. Mahoney, and M.J. Mirick Efficacy of pneumatic trousers in refractory prehospital cardiopulmonary arrest Ann Emerg Med 12 1983 8 12
9. G.B. Martin, R.M. Nowak, C.L. Emerman, and M.C. Tomlanovich Verapamil in the treatment of asystolic and pulseless idioventricular rhythm cardiopulmonary arrests: a preliminary report Ann Emerg Med 13 1984 221 225
10. J.R. Mateer, H.A. Stueven, B.M. Thompson, C. Aprahamian, and J.C. Darin Interposed abdominal compression CPR versus standard CPR in prehospital cardiopulmonary arrest: preliminary results Ann Emerg Med 13 1984 764 766
11. P.M. Paris, R.D. Stewart, and F. Deggler Prehospital use of dexamethasone in pulseless idioventricular rhythm Ann Emerg Med 13 1984 1008 1010
12. T. Silfvast, L. Saarnivaara, and A. Kinnunen Comparison of adrenaline and phenylephrine in out-of-hospital cardiopulmonary resuscitation. A double-blind study Acta Anaesthesiol Scand 29 1985 610 613
13. H.A. Stueven, B. Thompson, C. Aprahamian, D.J. Tonsfeld, and E.H. Kastenson Lack of effectiveness of calcium chloride in refractory asystole Ann Emerg Med 14 1985 630 632
14. I.F. Goldenberg, B.C. Campion, C.M. Siebold, J.W. McBride, and L.A. Long Esophageal gastric tube airway vs endotracheal tube in prehospital cardiopulmonary arrest Chest 90 1986 90 96
15. Brain Resuscitation Clinical Trial I Study Group A randomized clinical study of cardiopulmonary-cerebral resuscitation: design, methods, and patient characteristics Am J Emerg Med 4 1986 72 86
16. D.N. Quinton, G. O'Byrne, and A.R. Aitkenhead Comparison of endotracheal and peripheral intravenous adrenaline in cardiac arrest. Is the endotracheal route reliable? Lancet 1 1987 828 829
17. J.R. Hedges, S.A. Syverud, W.C. Dalsey, S. Feero, R. Easter, and B. Shultz Prehospital trial of emergency transcutaneous cardiac pacing Circulation 76 1987 1337 1343
18. L.M. Turner, M. Parsons, R.C. Luetkemeyer, J.C. Ruthman, R.J. Anderson, and J.C. Aldag A comparison of epinephrine and methoxamine for resuscitation from electromechanical dissociation in human beings Ann Emerg Med 17 1988 443 449
19. E. Barthell, P. Troiano, D. Olson, H.A. Stueven, and G. Hendley Prehospital external cardiac pacing: a prospective, controlled clinical trial Ann Emerg Med 17 1988 1221 1226
20. M. Forsman, H.P. Aarseth, H.K. Nordby, A. Skulberg, and P.A. Steen Effects of nimodipine on cerebral blood flow and cerebrospinal fluid pressure after cardiac arrest: correlation with neurologic outcome Anesth Analg 68 1989 436 443
21. J.P. Krischer, E.G. Fine, M.L. Weisfeldt, A.D. Guerci, E. Nagel, and N. Chandra Comparison of prehospital conventional and simultaneous compression-ventilation cardiopulmonary resuscitation Crit Care Med 17 1989 1263 1269
22. D.W. Olson, R. Thakur, and H.A. Stueven Randomized study of epinephrine versus methoxamine in prehospital ventricular fibrillation Ann Emerg Med 18 1989 250 253
23. 2 Ann Emerg Med 18 1989 831 837
24. R.O. Roine, M. Kaste, A. Kinnunen, P. Nikki, S. Sarna, and S. Kajaste Nimodipine after resuscitation from out-of-hospital ventricular fibrillation. A placebo-controlled, double-blind, randomized trial JAMA 264 1990 3171 3177
25. W.D. Weaver, C.E. Fahrenbruch, D.D. Johnson, A.P. Hallstrom, L.A. Cobb, and M.K. Copass Effect of epinephrine and lidocaine therapy on outcome after cardiac arrest due to ventricular fibrillation Circulation 82 1990 2027 2034
26. K.H. Lindner, F.W. Ahnefeld, and A.W. Prengel Comparison of standard and high-dose adrenaline in the resuscitation of asystole and electromechanical dissociation Acta Anaesthesiol Scand 35 1991 253 256
27. Brain Resuscitation Clinical Trial II Study Group A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest. Design, methods, and patient characteristics Control Clin Trials 12 1991 525 545
28. R.L. Bartlett, S.D. Martin, J.M. McMahon Jr., R.W. Schafermeyer, D.J. Vukich, and C.A. Hornung A field comparison of the pharyngeotracheal lumen airway and the endotracheal tube J Trauma 32 1992 280 284
29. C.G. Brown, D.R. Martin, and P.E. Pepe A comparison of standard-dose and high-dose epinephrine in cardiac arrest outside the hospital N Engl J Med 327 1992 1051 1055
30. M. Callaham, C.D. Madsen, C.W. Barton, C.E. Saunders, and J. Pointer A randomized clinical trial of high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital cardiac arrest JAMA 268 1992 2667 2672
31. T.J. Cohen, K.J. Tucker, and K.G. Lurie Active compression-decompression. A new method of cardiopulmonary resuscitation. Cardiopulmonary Resuscitation Working Group JAMA 267 1992 2916 2923
32. J.B. Sack, M.B. Kesselbrenner, and A. Jarrad Interposed abdominal compression-cardiopulmonary resuscitation and resuscitation outcome during asystole and electromechanical dissociation Circulation 86 1992 1692 1700
33. T.J. Cohen, B.G. Goldner, and P.C. Maccaro A comparison of active compression-decompression cardiopulmonary resuscitation with standard cardiopulmonary resuscitation for cardiac arrests occurring in the hospital N Engl J Med 329 1993 1918 1921
34. H.R. Halperin, J.E. Tsitlik, and M. Gelfand A preliminary study of cardiopulmonary resuscitation by circumferential compression of the chest with use of a pneumatic vest N Engl J Med 329 1993 762 768
35. W.T. Longstreth Jr., M.K. Copass, L.K. Dennis, M.E. Rauch-Matthews, M.S. Stark, and L.A. Cobb Intravenous glucose after out-of-hospital cardiopulmonary arrest: a community-based randomized trial Neurology 43 1993 2534 2541
36. W.D. Weaver, J.S. Martin, and M.J. Wirkus Influence of external defibrillator electrode polarity on cardiac resuscitation Pacing Clin Electrophysiol 16 1993 285 290
37. K.G. Lurie, J.J. Shultz, and M.L. Callaham Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest JAMA 271 1994 1405 1411
38. T. Staudinger, S. Brugger, and M. Roggla Comparison of the Combitube with the endotracheal tube in cardiopulmonary resuscitation in the prehospital phase Wien Klin Wochenschr 106 1994 412 415
39. C. Choux, P.Y. Gueugniaud, and A. Barbieux Standard doses versus repeated high doses of epinephrine in cardiac arrest outside the hospital Resuscitation 29 1995 3 9
40. T. Dybvik, T. Strand, and P.A. Steen Buffer therapy during out-of-hospital cardiopulmonary resuscitation Resuscitation 29 1995 89 95
41. G.A. Orliaguet, P.A. Carli, A. Rozenberg, D. Janniere, P. Sauval, and P. Delpech End-tidal carbon dioxide during out-of-hospital cardiac arrest resuscitation: comparison of active compression-decompression and standard CPR Ann Emerg Med 25 1995 48 51
42. T.M. Schwab, M.L. Callaham, C.D. Madsen, and T.A. Utecht A randomized clinical trial of active compression-decompression CPR vs standard CPR in out-of-hospital cardiac arrest in two cities JAMA 273 1995 1261 1268
43. K. Ellinger, T. Luiz, C. Denz, and K. van Ackern Randomized use of an active compression-decompression technique within the scope of preclinical resuscitation [German] Anasthesiol Intensivmed Notfallmed Schmerzther 29 1994 492 500
44. K.H. Lindner, B. Dirks, H.U. Strohmenger, A.W. Prengel, I.M. Lindner, and K.G. Lurie Randomised comparison of epinephrine and vasopressin in patients with out-of-hospital ventricular fibrillation Lancet 349 1997 535 537
45. P. Plaisance, F. Adnet, and E. Vicaut Benefit of active compression-decompression cardiopulmonary resuscitation as a prehospital advanced cardiac life support. A randomized multicenter study Circulation 95 1997 955 961
46. W.M. Hilty, P.A. Hudson, M.A. Levitt, and J.B. Hall Real-time ultrasound-guided femoral vein catheterization during cardiopulmonary resuscitation Ann Emerg Med 29 1997 331 336
47. T.J. Mader, and P. Gibson Adenosine receptor antagonism in refractory asystolic cardiac arrest: results of a human pilot study Resuscitation 35 1997 3 7
48. 2 detector and an esophageal aspiration device for verifying endotracheal tube placement in the prehospital setting: a six-month experience Prehosp Disaster Med 12 1997 57 63
49. B.W. Sherman, M.A. Munger, G.E. Foulke, W.F. Rutherford, and E.A. Panacek High-dose versus standard-dose epinephrine treatment of cardiac arrest after failure of standard therapy Pharmacotherapy 17 1997 242 247
50. M.C. Thel, A.L. Armstrong, S.E. McNulty, R.M. Califf, and C.M. O'Connor Randomised trial of magnesium in in-hospital cardiac arrest Lancet 350 1997 1272 1276
51. P.Y. Gueugniaud, P. Mols, and P. Goldstein A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group N Engl J Med 339 1998 1595 1601
52. J. Nolan, G. Smith, and R. Evans The United Kingdom pre-hospital study of active compression-decompression resuscitation Resuscitation 37 1998 119 125
53. E.T. Dickinson, V.P. Verdile, R.M. Schneider, and R.F. Salluzzo Effectiveness of mechanical versus manual chest compressions in out-of-hospital cardiac arrest resuscitation: a pilot study Am J Emerg Med 16 1998 289 292
54. E. Skogvoll, and L. Wik Active compression-decompression cardiopulmonary resuscitation: a population-based, prospective randomized clinical trial in out-of-hospital cardiac arrest Resuscitation 42 1999 163 172
55. P.J. Kudenchuk, L.A. Cobb, and M.K. Copass Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation N Engl J Med 341 1999 871 878
56. T.J. Mader, H.A. Smithline, and P. Gibson Aminophylline in undifferentiated out-of-hospital asystolic cardiac arrest Resuscitation 41 1999 39 45
57. A. Langhelle, K. Sunde, L. Wik, and P.A. Steen Arterial blood-gases with 500- versus 1000-ml tidal volumes during out-of-hospital CPR Resuscitation 45 2000 27 33
58. P. Plaisance, K.G. Lurie, and D. Payen Inspiratory impedance during active compression-decompression cardiopulmonary resuscitation: a randomized evaluation in patients in cardiac arrest Circulation 101 2000 989 994
59. J.M. Saissy, G. Boussignac, and E. Cheptel Efficacy of continuous insufflation of oxygen combined with active cardiac compression-decompression during out-of-hospital cardiorespiratory arrest Anesthesiology 92 2000 1523 1530
60. T. Schneider, P.R. Martens, and H. Paschen 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 2000 1780 1787
61. A. Hallstrom, L. Cobb, E. Johnson, and M. Copass Cardiopulmonary resuscitation by chest compression alone or with mouth-to-mouth ventilation N Engl J Med 342 2000 1546 1553
62. H.R. Arntz, R. Agrawal, and H. Richter Phased chest and abdominal compression-decompression versus conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest Circulation 104 2001 768 772
63. S. Hachimi-Idrissi, L. Corne, G. Ebinger, Y. Michotte, and L. Huyghens Mild hypothermia induced by a helmet device: a clinical feasibility study Resuscitation 51 2001 275 281
64. J. Allegra, R. Lavery, and R. Cody Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting Resuscitation 49 2001 245 249
65. T.B. Hassan, C. Jagger, and D.B. Barnett A randomised trial to investigate the efficacy of magnesium sulphate for refractory ventricular fibrillation Emerg Med J 19 2002 57 62
66. Hypothermia after Cardiac Arrest Study Group Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest N Engl J Med 346 2002 549 556
67. C.W. Callaway, S.C. Tadler, L.M. Katz, C.L. Lipinski, and E. Brader Feasibility of external cranial cooling during out-of-hospital cardiac arrest Resuscitation 52 2002 159 165
68. W.T. Longstreth Jr., C.E. Fahrenbruch, M. Olsufka, T.R. Walsh, M.K. Copass, and L.A. Cobb Randomized clinical trial of magnesium, diazepam, or both after out-of-hospital cardiac arrest Neurology 59 2002 506 514
69. W. Rabitsch, P. Schellongowski, and T. Staudinger Comparison of a conventional tracheal airway with the Combitube in an urban emergency medical services system run by physicians Resuscitation 57 2003 27 32
70. L. Wik, T.B. Hansen, and F. Fylling Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial JAMA 289 2003 1389 1395
71. A.P. van Alem, F.W. Chapman, P. Lank, A.A. Hart, and R.W. Koster A prospective, randomised, and blinded comparison of first shock success of monophasic and biphasic waveforms in out-of-hospital cardiac arrest Resuscitation 58 2003 17 24
72. B.B. Wolcke, D.K. Mauer, and M.F. Schoefmann 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 2003 2201 2205
73. T.J. Mader, H.A. Smithline, L. Durkin, and G. Scriver A randomized controlled trial of intravenous aminophylline for atropine-resistant out-of-hospital asystolic cardiac arrest Acad Emerg Med 10 2003 192 197
74. G. Nichol, E. Huszti, J. Rokosh, A. Dumbrell, J. McGowan, and L. Becker Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research? Resuscitation 62 2004 3 23
75. American Heart Association Advanced Cardiac Life Support 2002 American Heart Association Dallas, TX
76. V. Wenzel, A.C. Krismer, and H.R. Arntz A comparison of vasopressin and epinephrine for out-of-hospital cardiopulmonary resuscitation N Engl J Med 350 2004 105 113
77. T.D. Valenzuela, D.J. Roe, G. Nichol, L.L. Clark, D.W. Spaite, and R.G. Hardman Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos N Engl J Med 343 2000 1206 1209
78. L.L. Culley, T.D. Rea, and J.A. Murray Public access defibrillation in out-of-hospital cardiac arrest: a community-based study Circulation 109 2004 1859 1863
79. A.P. Hallstrom, J.P. Ornato, and M. Weisfeldt Public-access defibrillation and survival after out-of-hospital cardiac arrest N Engl J Med 351 2004 637 646
80. Heart Disease and Stroke Statistics - 2005 Update 2004 American Heart Association Dallas, TX
81. M.S. Eisenberg, and T.J. Mengert Cardiac resuscitation N Engl J Med 344 2001 1304 1313
82. L.A. Cobb, C.E. Fahrenbruch, M. Olsufka, and M.K. Copass Changing incidence of out-of-hospital ventricular fibrillation, 1980-2000 JAMA 288 2002 3008 3013