Appendix F:
Published EMS Randomized Clinical Trials
The following table is a listing of major randomized or pseudo-randomized clinical trials completed in the prehospital setting.
Modified with permission from the BMJ Publishing Group from a table by Brazier H, Murphy AW, Lynch C, Bury G. Searching for the evidence in pre-hospital care: a review of randomised controlled trials. On behalf of the Ambulance Response Time Sub-Group of the National Ambulance Advisory Committee. J Accid Emerg Med 1999; 16(1):18-23. The original table is available on the Internet at www.rcsi.ie/library/prehospital_care.html.
|
Trial |
Patients |
Setting |
N |
Intervention |
Main
Result |
| Valentine et al. 197440 | Adults younger than 70 with high suspicion for AMI | Multicenter, Australia | 269 | Physician intramuscular injection of (a) lidocaine or (b) placebo | During first two hours after injection, 5% absolute reduction in mortality (p<0.04) |
| Hampton and Nicholas 197841 | Adult patients without motor-vehicle trauma | Nottingham, England | 3,340 | (a) Transport by mobile coronary care unit or (b) routine transport | 2% absolute reduction in mortality from heart attacks (NS) |
| Diederich et al. 197942 | Acute myocardial infarction patients younger than 70 | Lubeck, Germany |
|
Intramuscular injection of (a) lidocaine or (b) placebo | Mortality lower in lidocaine group. |
| Mahoney and Mirick 1983105 | Cardiac arrest patients older than 20 | Minneapolis, Minnesota | 136 | (a) Pneumatic antishock garments or (b) usual care | Survival to hospital discharge was 9% in (a) and 4% in (b) (NS). |
| Mateer et al. 1984106 | Cardiac arrest patients | Milwaukee, Wisconsin | 140 | After endotracheal intubation either (a) interposed abdominal compression CPR (IAC-CPR) or (b) standard CPR | 4% absolute increase in patients admitted to ED with a pulse (NS) |
| Olson et al. 1984107 | Ventricular fibrillation persisting after initial shocks | Milwaukee, Wisconsin | 92 | (a) Bretylium and then, if VF persists, lidocaine or (b) lidocaine and then, if VF persists, bretylium | Survival to hospital discharge was 5% in bretylium first group vs 10% in lidocaine first group (NS) |
| Paris et al. 1984108 | Cardiac arrest patients with pulseless idioventricular rhythm | Pittsburgh, Pennsylvania | 86 | (a) Dexamethasone 100 mg or (b) saline placebo | No long term survivors in either group |
| Stueven et al. 1984109 | Witnessed non-traumatic adult cardiac arrest patients with asystole and not responding to epinephrine, bicarbonate, or atropine | Milwaukee, Wisconsin | 32 | (a) Calcium chloride or (b) saline placebo | No long term survivors in either group |
| Bickell et al. 1985110 | Injured patients with hypotension | Houston, Texas | 68 | (a) Pneumatic antishock garments or (b) usual care | No difference in presenting emergency department trauma score |
| Mateer et al. 1985111 | Same as Mateer et al. 1984106 | Milwaukee, Wisconsin | 291 | After endotracheal intubation either (a) interposed abdominal compression CPR (IAC-CPR) or (b) standard CPR | 3% absolute decrease in patients admitted to ED with a pulse (NS) |
| Silfvast et al. 1985112 | Patients with cardiac arrest | Helsinki, Finland | 65 | (a) Phenylephrine 1 mg or (b) epinephrine 0.5 mg intravenously | 3% absolute increase in patients with “successful” resuscitation (NS) |
| Stueven et al. 1985a113 | Cardiac arrest patients with asystole as in Stueven et al. 1984109 | Milwaukee, Wisconsin | 73 | (a) Calcium chloride or (b) saline placebo | No long term survivors in either group |
| Stueven et al. 1985b114 | Cardiac arrest patients with electromechanical dissociation who did not respond to epinephrine and bicarbonate | Milwaukee, Wisconsin | 90 | (a) Calcium chloride or (b) saline placebo | 16% of patients receiving calcium were admitted to the emergency department with a pulse vs 5% of controls. Only one patient was a long term survivor. |
| Goldenberg et al. 1986115 | Cardiac arrest patients | St. Paul, Minnesota | 175 | Airway managed with either (a) esophageal gastric tube airway (EGTA) or (b) endotracheal intubation (ETI) | Training in use of EGTA cost less than ETI. Survival to hospital discharge 12.9% vs 11.1%. |
| Hargarten et al. 1986116 | Stable patients with chest pain | Milwaukee, Wisconsin | 446 | (a) Lidocaine or (b) usual care | 1.4% absolute decrease in hospital mortality (NS). Four patients with sudden death in each group (NS). |
| Mattox et al. 1986117 | Injured patients with systolic BP <90mm Hg | Houston, Texas | 352 | (a) Pneumatic antishock garments or (b) usual care | No difference in mortality (NS). |
| Baxt and Moody 1987118 | Trauma patients requiring resuscitation transported by helicopter |
San Diego, California
|
545
|
Helicopter staffed by (a) flight nurse and paramedic or (b) flight nurse and physician | Mortality of patients treated by flight nurse / physician team was lower than that of patients treated by flight nurse / paramedic (p<0.05), and lower than predicted by TRISS (p<0.05) |
| Bickell et al. 1987119 | Victims of gunshot or stab wounds to anterior abdomen with a systolic BP <90mm Hg | Houston, Texas | 201 | (a) Pneumatic antishock garments or (b) usual care | 8.8% absolute increase in mortality at hospital discharge (NS) |
| Castaigne et al. 1987120 | Patients seen within three hours of symptoms suggesting AMI who had a qualifying ECG |
Val de Marne, France
|
25 | Administration by non-cardiologist staffed mobile care unit of (a) anisoylated plasminogen streptokinase activator complex (APSAC) or (b) placebo | Thrombolytic drug treatment started 56 minutes sooner after onset of pain in mobile care unit group than in control group. |
| Cummins et al. 1987121 | Patients in cardiac arrest | Seattle, Washington | 321 | Use by EMT of (a) automated external defibrillator (AED) or (b) standard defibrillator | 7% absolute reduction in mortality at hospital discharge (NS). Time from power on to first shock 0.9 minutes faster in AED group. |
| Hedges et al. 1987122 | Patients in asystole or with hemodynamically significant bradycardia | Thurston County, Washington | 202 |
(a) Prehospital transcutaneous cardiac pacing or (b) usual care
|
1.9% absolute reduction in mortality at hospital discharge (NS) |
|
Hoffman and Reynolds 1987123
|
Patients whose chief complaint was dyspnea and who had a presumed diagnosis of cardiogenic pulmonary edema | Los Angeles County |
57
|
Administration by paramedic of (a) SL nitroglycerin and IV furosemide, or (b) IV morphine and furosemide, or (c) all three, or (d) IV morphine and SL nitroglycerin | No difference at hospital discharge. |
| Barthell et al. 1988124 | Patients in asystole or with hemodynamically significant bradycardia | Milwaukee, Wisconsin | 239 | (a) External cardiac pacing device or (b) usual care | 2.4% absolute reduction in mortality at hospital discharge (NS) |
|
DuBoise-Rande et al. 1989125 Castaigne et al. 1989126 |
Patients seen within three hours of symptoms who had a qualifying ECG
|
Val de Marne, France | 93 |
(a) Administration of APSAC by anaesthesiologist staffed mobile care unit or
(b) inhospital treatment
|
0.3% (NS) reduction in mortality in the prehospital group at hospital discharge. |
| Krischer et al. 1989127 | Adults with non-traumatic out of hospital cardiac arrest | Florida | 702 | (a) Simultaneous compression-ventilation (SC-V) CPR or (b) standard CPR | 6.8% increase in mortality (p<0.01) at hospital discharge |
| Mattox et al. 198950 | Injured patients with systolic BP <90mm Hg | Houston, Texas | 911 | (a) Pneumatic antishock garment or (b) usual care | 6% absolute increase in mortality at hospital discharge (p=0.05) |
| Olson et al. 1989128 | Pulseless, nonbreathing patients with initial cardiac rhythm of ventricular fibrillation | Milwaukee, Wisconsin | 102 | Administration by paramedic of repeated IV doses of (a) epinephrine or (b) methoxamine | 11.8% (NS) at hospital discharge |
| Barbash et al. 1990129 | AMI patients seen within four hours of symptoms who had a qualifying ECG and confirmed for inclusion by remote physician | Israel | 87 | (a) Administration of recombinant tissue-type plasminogen activator (rt-PA) by physician and paramedic staffed mobile coronary care unit or (b) inhospital treatment | 4.5% (NS) reduction in mortality in (a) at 60 days. |
|
Hargarten et al. 1990130
|
Patients seen with symptoms suggestive of AMI and confirmed for inclusion by remote physician after ECG review |
Milwaukee, Wisconsin
|
1,427
|
Administration by paramedic of (a) IV lidocaine bolus and infusion or (b) placebo | 1.5% increase in mortality (NS) at hospital discharge |
| Karagounis et al. 1990131 | Patients clinically suspected of having an AMI | Salt Lake City, Utah | 71 | (a) Prehospital cellular transmission of 12-lead ECG or (b) no prehospital ECG | In-field ECG caused negligible delays in on-scene and transport time |
| Roine et al. 1990132 | Patients resuscitated from ventricular fibrillation | Helsinki, Finland | 155 | (a) Initiation of IV nimodipine 10 mcg/kg with 24 hour infusion or (b) placebo by physician staffed advance life support unit | 4% reduction in mortality at one year in nimodipine group (NS) |
|
Schofer et al. 1990133 Mathey et al. 1990134 |
AMI patients seen within four hours of symptoms who had a qualifying ECG | Hamburg, Germany | 78 | (a) Administration of IV urokinase by physician and emergency medical technician staffed mobile coronary care unit or (b) inhospital treatment | 2.8% (NS) reduction in mortality in (a) at hospital discharge. |
| Mattox et al. 1991135 | Trauma patients with systolic BP <90mm Hg | Multicenter, USA | 359 | Administration of (a) 7.5% NaCl with 6% Dextran or (b) lactated Ringers | Absolute reduction in mortality of 3.3% (NS); 7.5% NaCl/Dextran significantly increased BP (p<0.05) |
| Risenfors et al. 1991136 | AMI patients seen within 2.75 hours of symptoms | Göteborg, Sweden | 101 | Administration by cardiologist staffed mobile coronary care unit of (a) rt-PA or (b) placebo | 8.7% (NS) reduction in mortality in (a) at hospital discharge |
| Vassar et al. 1991137 | Trauma patients transported by helicopter with systolic BP <100mm Hg | Sacramento California |
166
|
Administration of (a) 7.5% NaCl with 4.2% Dextran or (b) lactated Ringers | Absolute reduction in mortality of 4.8% (NS); 7.5% NaCl/Dextran significantly increased BP (p<0.05) |
| Berntsen and Rasmussen 1992138 | Patients seen within six hours of symptoms suggestive of AMI |
Norway
|
204
|
Administration by general practitioner of (a) IV bolus and IM injection of lidocaine or (b) placebo | 4.8% (NS) at hospital discharge; 0.9% (NS) absolute reduction in ventricular fibrillation |
| Brown et al. 1992139 | Adult cardiac arrest patients | Multicenter, USA | 1,280 | Administration by paramedic of (a) high dose epinephrine or (b) standard dose epinephrine | 1% absolute reduction in mortality at hospital discharge (NS). |
|
Callaham et al. 1992140
|
Nontraumatic cardiac arrest patients | San Francisco |
816
|
Administration by paramedic of (a) high dose epinephrine or (b) high dose epinephrine bitartrate or (c) standard dose epinephrine | No difference at hospital discharge |
| GREAT Group 1992141 | Patients with AMI seen at home by general practioners within 4 hours of symptom onset | Grampian region, Scotland | 311 | (a) APSAC 30 units at home and placebo in hospital or (b) placebo at home and APSAC 30 units in hospital | 7.6% absolute reduction in 3 month mortality for group with thrombolysis started at home (95% CI 14.7% to 0.4%). |
| Kereiakes et al. 1992142 | Patients with AMI confirmed by serial ECGs and enzyme analysis | Cincinnati, Ohio | 22 | (a) Prehospital cellular transmission of 12-lead ECG or (b) no prehospital ECG | Significant reduction in hospital delay to initiation of thrombolytic therapy (p<0.005) |
| Karpov et al. 1992143 | Patients with suspected AMI | Russia | 200 | (a) Prehospital administration of IV streptokinase and heparin by cardiologist or (b) inhospital administration or (c) usual care | 6% (NS) reduction in mortality for (a) vs. (b) at 30 days; 10% (p<0.05) for (a) vs. (c) at 30 days |
| McAleer et al. 1992144 | AMI patients seen within six hours of symptoms who had a qualifying ECG | Enniskillen, Northern Ireland | 145 | (a) Administration of IV streptokinase by physician staffed mobile coronary care unit or (b) inhospital treatment | 21.5% (p<0.05) reduction in mortality in (a) at two years |
| Stiell et al. 1992145 | Patients with cardiac arrest | Ottawa, Ontario, Canada | 335 | Administration of (a) high-dose epinephrine or (b) standard dose epinephrine | 2% absolute increase in mortality at hospital discharge (NS) |
| Bertini et al. 1993146 | Patients seen within six hours of symptoms suggestive of AMI who had a qualifying ECG | Florence, Italy | 60 | Administration by cardiologist and paramedic staffed mobile coronary care unit of (a) lidocaine bolus and infusion or (b) placebo | 4.1% (NS) at hospital discharge; 15.2% (p<0.05) absolute reduction in ventricular fibrillation |
|
EMIP Group 1993147 Boissel 1995148 |
Patients seen within six hours of symptoms who had a qualifying ECG | Europe and Canada | 5,469 | Administration by emergency medical personnel of (a) IV anistreplase or (b) placebo | 1.4% (NS) reduction in mortality in (a) at 30 days |
| Longstreth et al. 1993149 | Cardiac arrest patients | Seattle, Washington | 748 | Administration of intravenous maintenance solutions containing either (a) 5% dextrose in water (D5W) or (b) half normal saline | 1.8% reduction in mortality in the D5W group at hospital discharge (NS) |
| Vassar et al. 1993150 | Trauma patients transported by helicopter, with systolic BP <90 mm Hg | Multicenter, USA | 194 | Administration of (a) lactated Ringers or (b) 7.5% NaCl or (c) 7.5% NaCl with 6% Dextran or (d) 7.5%NaCl with 12% Dextran | Mortality in the 7.5% NaCl group was significantly lower than predicted by TRISS (p<0.001); adding Dextran made no difference. |
| Vassar et al. 1993151 | Trauma patients with systolic BP <90 mm Hg | Sacramento California | 258 | Administration of (a) normal saline or (b) 7.5% NaCl or (c) 7.5% NaCl with 6% Dextran | Mortality in the 7.5% NaCl group was significantly lower than predicted by TRISS (p<0.025); adding Dextran made no difference. |
| Weaver et al. 1993152 | Patients seen within six hours of symptoms who had a qualifying ECG and confirmed for inclusion by remote physician |
Seattle, Washington
|
360 |
(a) Administration of aspirin and alteplase by paramedic or (b) inhospital
treatment
|
2.4% (NS) reduction in mortality in (a) at 30 days |
| Bickell et al. 1994153 | Adults with penetrating torso injuries and systolic BP <90mm Hg | Houston, Texas | 598 | (a) Immediate fluid resuscitation in field or (b) delayed fluid resuscitation in operating suite | 8% absolute reduction in mortality at hospital discharge for the group receiving delayed fluid resuscitation (OR 0.70, 95% CI 0.50 – 0.99, p = 0.04) |
| Ellinger et al. 1994154 | Patients in cardiac arrest | Mannheim, Germany | 56 | (a) Active compression decompression CPR (ACD-CPR) or (b) standard CPR | 1.8% increase in mortality in ACD-CPR group at hospital discharge (NS). |
| EMIP-BB Group 1994155 | Patients seen within two hours of symptoms suggestive of AMI who had a qualifying ECG | Lyon, France | 77 | Administration by emergency medical personnel of (a) IV atenolol or (b) placebo | 0.7% difference in mortality at hospital discharge (NS) |
| Rhee and O’Malley 1994156 | Injured adults with GCS <8 transported by helicopter | Sacramento, California |
77
|
Performance by flight nurses of (a) nasotracheal intubation or (b) neuromuscular blockade-assisted oral intubation | No difference in success rate; nasotracheal intubation required significantly less time to perform (p<0.01) |
| Staudinger et al. 1994157 | Out of hospital cardiac arrests | Valparaiso, Indiana | 80 | Intubation with (a) “Combitube” combined endotracheal and esophageal obturator airway adjunct or (b) standard endotracheal tube | 0.5% absolute reduction in mortality at hospital discharge (NS) |
| Choux et al. 1995158 | Prehospital cardiac arrest patients | Paris, France | 536 | (a) High-dose epinephrine or (b) standard dose epinephrine | 3.6% increase in admission to hospital in (a) and 3.7% increase in survival at 6 months in (a) (NS). |
|
Dybvik et al. 1995159 Dybvik et al. 1996160 |
Adult cardiac arrest patients with asystole or ventricular fibrillation persisting after one shock | Oslo, Norway | 502 | (a) 250 ml of sodium bicarbonate-trometamol-phosphate mixture with buffering capacity 500 mmol/l or (b) 250 ml of 0.9% saline |
4% decrease in survival to hospital discharge in buffer therapy group
(NS). |
| Quadrel et al. 1995161 | Known adult asthmatics with wheeze | New Jersey | 154 | Administration by paramedic of (a) SC epinephrine, or (b) nebulized metaproterenol or (c) SC epinephrine and nebulized metaproterenol | Nebulized metaproterenol is as effective as SC epinephrine; the combination of the two drugs offered no additional benefit |
| Schwab et al. 1995162 | Normothermic adult victims of out-of- hospital, nontraumatic cardiac arrest on whom CPR was performed by first responders | San Francisco and Fresno, California | 860 | First responders did either (a) active compression-decompression CPR (ACD-CPR) or (b) standard CPR | 1% decrease in survival to hospital discharge in ACD-CPR group (NS). |
| Weiss et al. 1995163 | Patients transported by paramedical ambulance service | New Orleans, Louisiana | 182 | (a) Tympanic membrane thermometry or (b) usual care | Acceptable correlation with gold standard |
| Zehner et al. 1995102 | Adults with respiratory distress | Syracuse, New York | 83 | Paramedics administered either (a) albuterol aerosol and saline injection or (b) saline aerosol and terbutaline injection | Albuterol group had greater improvement in respiratory distress score by hospital arrival. |
| Brouwer et al. 1996164 | As in Weaver et al. 1993152 | Seattle, Washington | 360 | As in Weaver et al. 1993152 | 2% increase in mortality (NS) at two years. |
| Luiz et al. 1996165 | Out of hospital cardiac arrests | Mannheim, Germany | 56 | (a) Active compression-decompression (ACD) or (b) standard CPR | 1.8% increase in mortality (NS) at hospital discharge |
| Mauer et al. 1996166 | Out of hospital cardiac arrest patients | Mainz, Germany | 220 | (a) Active compression-decompression CPR (ACD-CPR) or (b) standard CPR | 2% decrease in mortality (NS) at hospital discharge |
| Sayre et al. 1996167 | Helicopter transported and intubated patients with a head injury |
Cincinnati, Ohio
|
41
|
Administration by emergency physician of (a) IV 20% mannitol or (b) 0.9% saline | No change in systolic BP over a 2-hour period |
| Stiell et al. 1996168 | Out of hospital cardiac arrests | Ontario, Canada | 1,011 | (a) ACD or (b) standard CPR | 1.7% (NS) absolute reduction in mortality in (a) at 1 hour; 0.9% (NS) at hospital discharge |
| Lindner et al. 1997169 | Cardiac arrest patients in ventricular fibrillation unresponsive to defibrillation | Ulm, Germany | 40 | (a) epinephrine or (b) vasopressin | At 24 hours, 40% absolute reduction in mortality (P <0.02); at hospital discharge, 25% absolute reduction in mortality (NS). |
| Mader and Gibson 1997170 | Nontraumatic, asystolic cardiac arrest patients | Springfield, Massachusetts | 22 | (a) aminophylline or (b) placebo | Half of aminophylline patients had organized rhythm compared with none of the placebo patients (P=0.02). |
| Plaisance et al. 1997171 | Out of hospital cardiac arrests confirmed by ECG |
France
|
512
|
(a) ACD or (b) standard CPR | 12.4% (p<0.005) absolute reduction in mortality (a) at 24 hours; 3.2% (NS) at 1 month |
| Rosen et al. 1997172 | Male combative patients | Denver, Colorado |
46
|
Administration by paramedics of (a) IV droperidol or (b) placebo | Patients significantly less agitated (p<0.001) after 10 minutes |
| Rumball et al. 1997173 | Patients requiring advanced airway management | Canada | 470 | Three different airway management techniques: pharyngeal tracheal lumen airway (PTL), combitube (Combi), and laryngeal mask airway (LMA) | Successful insertion and ventilation: Combi, 86%; PTL, 82%; LMA, 73% (p = 0.048) |
| Gueugniaud et al. 1998174 | Adult cardiac arrest patients | Multicenter, Europe | 3327 | (a) High dose epinephrine or (b) standard dose epinephrine | 0.5% absolute increase in mortality at hospital discharge (NS). |
| Gardtman et al. 1999175 | Suspected AMI patients with ongoing chest pain | Göteborg, Sweden | 262 | Morphine 5 mg IV followed by (a) metoprolol 5 mg IV x 3 in 2 minute intervals or (b) placebo IV x 3 | Arbitrary 10 point chest pain score decreased by 3 units in (a) and 2.6 units in (b) (NS). |
| Kudenchuk et al. 1999176 | Cardiac arrest patients with ventricular fibrillation not responding to three shocks | Seattle, Washington | 504 | (a) IV amiodarone or (b) placebo | 10% absolute decrease in mortality at hospital admission (P=0.03); no difference at hospital discharge (NS). |
| Mader et al. 1999177 | Nontraumatic, asystolic cardiac arrest | Springfield, Massachusetts | 82 | (a) aminophylline or (b) placebo | 7% increase in return of spontaneous circulation (NS). |
| Plaisance et al. 199981 | Cardiac arrest patients | Paris and Thionville, France | 750 | (a) ACD-CPR or (b) standard CPR | 4% absolute decrease in mortality at hospital discharge (P=0.01) and 3% absolute decrease in mortality at one year (P=0.03). |
| Skogvoll and Wik 1999178 | Cardiac arrest patients of presumed cardiac origin | Trondheim, Norway | 302 | (a) ACD-CPR or (b) standard CPR | 1% absolute decrease in mortality at hospital discharge (NS). |
| Gausche et al. 200018 | Pediatric patients £ 12 years of age or 40 kg bodyweight requiring prehospital airway management | Los Angeles and Orange Counties, California | 830 | Scope of paramedic practice alternates between (a) bag-mask ventilation with endotracheal intubation (ETI) or (b) bag-mask ventilation alone | Absolute mortality in ETI group was 4% higher than bag-mask ventilation alone group (NS). |
| Plaisance et al. 2000179 | Nontraumatic cardiac arrest patients | Paris, France | 21 | (a) ACD-CPR with an impedance threshold valve or (b) ACD-CPR | Maximal end-tidal CO2, coronary perfusion pressure, and diastolic blood pressure were all higher in group (a) (P<0.01). |
| Schneider et al. 2000180 | Ventricular fibrillation patients with an AED used | Multicenter, Europe | 115 | (a) AED using 150 j biphasic waveform or (b) 200 j to 260 j monophasic waveform | 98% defibrillated in first three shocks using biphasic waveform vs 69% using monophasic waveform (P<0.0001). |
| Turner et al. 2000181 | Adult trauma patients—hypotensive | Multicenter, England | 1,309 | (a) IV fluids started at scene or (b) no prehospital IV fluids | Absolute mortality was 0.4% lower in the group not getting prehospital IV fluids (NS). |
ACD = active compression-decompression; AED = automated external defibrillator; AMI = acute myocardial infarction; APSAC = anisoylated plasminogen-streptokinase activator complex; BP = blood pressure; CI = confidence interval; CPR = cardiopulmonary resuscitation; CO2 = carbon dioxide; ECG = electrocardiography; GCS = Glasgow Coma Scale score; IM = intramuscular; IV = intravenous; NaCl = sodium chloride; NS = not significant; OR = odds ration; rt-PA = recombinant tissue plasminogen activator; SC = subcutaneous; TRISS = trauma and injury severity score.
