Index
Abstract
Dedication
Preface
Definition of EMS for this Document
Federal Agencies Can Help Advance EMS Research
Executive Summary
Introduction
History of EMS Research
The Present State of EMS Research
Overcoming the Barriers to EMS Research
Summary
Appendix A: The National EMS Research Agenda Writing Team
Appendix B: Organizations Invited to Participate in the National Review Team
Appendix C: Ethical Standards and IRB Requirements
Appendix D Inclusion Of Women And Minorities In Research Study Populations Involving Human Subjects
Inclusion Of Children As Participants In Research Involving Human Subjects
Appendix E: Bibliographic List of Internet Links
Appendix F: Published EMS Randomized Clinical Trials
References

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

G�teborg, 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

G�teborg, 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.