SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation

This study has been completed.

Sponsor:

Collaborators:

Philips Medical Systems

London Ambulance Service

Information provided by:

New York City Fire Department

ClinicalTrials.gov Identifier:

NCT00535106

First received: September 25, 2007

Last updated: October 18, 2009

Last verified: October 2009

History of Changes

Purpose

This study is designed to examine the impact of an available technology within an automated external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular fibrillation.

Condition	Intervention
Ventricular Fibrillation Cardiac Arrest	Device: Automated external defibrillator (Philips FR2+ AED) Device: SmartCPR Other: Delayed defibrillation


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	An International, Randomized, Controlled Prehospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Health Facilities

Genetic and Rare Diseases Information Center resources: Paroxysmal Ventricular Fibrillation

U.S. FDA Resources

Further study details as provided by New York City Fire Department:

Primary Outcome Measures:

Survival to Hospital Discharge [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival to hospital admission [ Time Frame: within hours from the time of arrest ] [ Designated as safety issue: No ]
Return of spontaneous circulation (ROSC) in prehospital setting [ Time Frame: Variable (depends on EMS contact time) ] [ Designated as safety issue: No ]
Neurological status among survivors [ Time Frame: Variable (measured at hospital discharge) ] [ Designated as safety issue: No ]
Survival (defined as ROSC, survival to hospital admission, and survival to hospital discharge) as compared to a "delayed defibrillation" cohort in NYC [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Impact of CPR interval on VF waveform characteristics [ Time Frame: Immediately after CPR interval ] [ Designated as safety issue: No ]
Utility of AED algorithm and VF characteristics among EMS-witnessed arrests [ Time Frame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Utility of this AED technology and VF characteristics among pediatric patients [ Time Frame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Impact of bystander CPR on VF waveform characteristics [ Time Frame: Immediate (taken from data during arrest) ] [ Designated as safety issue: No ]
Comparison of EMS response times to VF waveform characteristics [ Time Frame: Immediate (data obtained during EMS response and arrest period) ] [ Designated as safety issue: No ]
Frequency of unmanageable airways in out-of-hospital cardiac arrest patients [ Time Frame: Immediate (measured at the time of arrest) ] [ Designated as safety issue: No ]
Impact of patient race upon the provision of bystander CPR, VF waveform characteristics, and survival [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Relationship between presenting and interval waveform capnography readings and survival [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Frequency of organ donation among out-of-hospital cardiac arrest patients transported to the hospital who do not survive to hospital discharge [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Waveform characteristics among patients presenting in secondary VF (initial presenting rhythm asystole or pulseless electrical activity) [ Time Frame: Immediate (derived from data collected during the arrest) ] [ Designated as safety issue: No ]
Description of and outcomes of patients for whom intraosseous access is utilized during the cardiac arrest [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Utstein comparison of two cities (London and New York) [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Impact of bystander CPR on survival as a function of response time [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
Association between ambient small particle (PM2.5) pollution and cardiac arrest indicence in New York City [ Time Frame: To be determined by modelling ] [ Designated as safety issue: No ]


Enrollment:	900
Study Start Date:	May 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard resusc Patients in this arm will be treated with standard resuscitation efforts, including the delivery of an immediate defibrillatory shock for all patients presenting in VF.	Device: Automated external defibrillator (Philips FR2+ AED) Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts. Other Name: Philips FR2+ AED
Experimental: SmartCPR Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient.	Device: SmartCPR Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient.
Active Comparator: Delayed defib In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation. Data is being collected on this population as well, thereby providing a cohort population for comparative purposes.	Other: Delayed defibrillation In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.

Show Detailed Description

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

initial treatment includes application of a study AED
complete initial waveform analysis
presenting rhythm is ventricular fibrillation
arrest of cardiac etiology

Exclusion Criteria:

arrest of noncardiac etiology
initial treatment with a non-study defibrillator
missing AED data
age <18 (London only)
resuscitation terminated due to a DNR order / decision

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535106

Locations


United States, New York
New York City Fire Department
New York, New York, United States, 11201
United Kingdom
London Ambulance Service
London, England, United Kingdom

Sponsors and Collaborators

New York City Fire Department

Philips Medical Systems

London Ambulance Service

Investigators


Principal Investigator:	John P Freese, MD	New York City Fire Department
Study Director:	Bradley J Kaufman, MD, MPH	New York City Fire Department
Study Director:	Rachael Donohoe, PhD	London Ambulance Service
Study Director:	Dawn Jorgenson, PhD	Philips Medical Systems

More Information

Additional Information:

FDNY webpages specific to the SmartCPR Trial This link exits the ClinicalTrials.gov site

Publications:

Cobb LA, Fahrenbruch CE, Olsufka M, Copass MK. Changing incidence of out-of-hospital ventricular fibrillation, 1980-2000. JAMA. 2002 Dec 18;288(23):3008-13.

Niemann JT, Cairns CB, Sharma J, Lewis RJ. Treatment of prolonged ventricular fibrillation. Immediate countershock versus high-dose epinephrine and CPR preceding countershock. Circulation. 1992 Jan;85(1):281-7.

Angelos MG, Stoner JD. Cardiopulmonary resuscitation, ventilation, defibrillation: in what order? Ann Emerg Med. 2002 Dec;40(6):571-4.

Valenzuela TD. Priming the pump--can delaying defibrillation improve survival after sudden cardiac death? JAMA. 2003 Mar 19;289(11):1434-6.

Valenzuela TD, Roe DJ, Nichol G, Clark LL, Spaite DW, Hardman RG. Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos. N Engl J Med. 2000 Oct 26;343(17):1206-9.

Eftestøl T, Losert H, Kramer-Johansen J, Wik L, Sterz F, Steen PA. Independent evaluation of a defibrillation outcome predictor for out-of-hospital cardiac arrested patients. Resuscitation. 2005 Oct;67(1):55-61.

Eftestøl T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. Epub 2004 Jun 21.

Wik L, Hansen TB, Fylling F, Steen T, Vaagenes P, Auestad BH, Steen PA. Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial. JAMA. 2003 Mar 19;289(11):1389-95.

Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7.

Cobb LA, Fahrenbruch CE, Walsh TR, Copass MK, Olsufka M, Breskin M, Hallstrom AP. Influence of cardiopulmonary resuscitation prior to defibrillation in patients with out-of-hospital ventricular fibrillation. JAMA. 1999 Apr 7;281(13):1182-8.

Heightman AJ. Eagle Creek report: results of the 2-day consensus retreat on leading controversies in EMS. JEMS. 2004 Sep;29(9):suppl 7-9.

Snyder DE, White RD, Jorgenson DB. Outcome prediction for guidance of initial resuscitation protocol: Shock first or CPR first. Resuscitation. 2007 Jan;72(1):45-51. Epub 2006 Nov 14.

American Heart Association. 2005 American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) of pediatric and neonatal patients: pediatric basic life support. Pediatrics. 2006 May;117(5):e989-1004.

International Liaison Committee on Resuscitation. The International Liaison Committee on Resuscitation (ILCOR) consensus on science with treatment recommendations for pediatric and neonatal patients: pediatric basic and advanced life support. Pediatrics. 2006 May;117(5):e955-77. Epub 2006 Apr 17.

Hazinski MF, Nadkarni VM, Hickey RW, O'Connor R, Becker LB, Zaritsky A. Major changes in the 2005 AHA Guidelines for CPR and ECC: reaching the tipping point for change. Circulation. 2005 Dec 13;112(24 Suppl):IV206-11. Epub 2005 Nov 28.

Ristagno G, Gullo A. Is ventricular fibrillation waveform analysis suitable for optimizing timing of ventricular defibrillation? Yes it is. Crit Care Med. 2007 Jul;35(7):1804-5; author reply 1805.

Russell JK, White RD, Crone WE. Analysis of the ventricular fibrillation waveform in refibrillation. Crit Care Med. 2006 Dec;34(12 Suppl):S432-7.

Sherman LD. The frequency ratio: an improved method to estimate ventricular fibrillation duration based on Fourier analysis of the waveform. Resuscitation. 2006 Jun;69(3):479-86. Epub 2006 Mar 23.

Callaway CW, Menegazzi JJ. Waveform analysis of ventricular fibrillation to predict defibrillation. Curr Opin Crit Care. 2005 Jun;11(3):192-9. Review.

Pepe PE, Fowler RL, Roppolo LP, Wigginton JG. Clinical review: Reappraising the concept of immediate defibrillatory attempts for out-of-hospital ventricular fibrillation. Crit Care. 2004 Feb;8(1):41-5. Epub 2003 Sep 29. Review.

Menegazzi JJ, Callaway CW, Sherman LD, Hostler DP, Wang HE, Fertig KC, Logue ES. Ventricular fibrillation scaling exponent can guide timing of defibrillation and other therapies. Circulation. 2004 Feb 24;109(7):926-31. Epub 2004 Feb 2.

Lederer W, Rheinberger K, Lischke V, Amann A. [Analysis of ventricular fibrillation signals for the evaluation of defibrillation success in the treatment of ventricular fibrillation]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003 Dec;38(12):787-94. Review. German.

Lightfoot CB, Nremt-P, Callaway CW, Hsieh M, Fertig KC, Sherman LD, Menegazzi JJ. Dynamic nature of electrocardiographic waveform predicts rescue shock outcome in porcine ventricular fibrillation. Ann Emerg Med. 2003 Aug;42(2):230-41.

Reed MJ, Clegg GR, Robertson CE. Analysing the ventricular fibrillation waveform. Resuscitation. 2003 Apr;57(1):11-20. Review.

Berg RA, Hilwig RW, Kern KB, Ewy GA. Precountershock cardiopulmonary resuscitation improves ventricular fibrillation median frequency and myocardial readiness for successful defibrillation from prolonged ventricular fibrillation: a randomized, controlled swine study. Ann Emerg Med. 2002 Dec;40(6):563-70.

Gazmuri RJ, Ayoub IM, Shakeri SA. Ventricular fibrillation waveform analysis for guiding the time of electrical defibrillation. Crit Care Med. 2001 Dec;29(12):2395-7.

Wang HE, Menegazzi JJ, Lightfoot CB, Callaway CW, Fertig KC, Sherman LD, Hsieh M. Effects of biphasic vs monophasic defibrillation on the scaling exponent in a swine model of prolonged ventricular fibrillation. Acad Emerg Med. 2001 Aug;8(8):771-80.

Callaway CW, Sherman LD, Mosesso VN Jr, Dietrich TJ, Holt E, Clarkson MC. Scaling exponent predicts defibrillation success for out-of-hospital ventricular fibrillation cardiac arrest. Circulation. 2001 Mar 27;103(12):1656-61.

Povoas HP, Bisera J. Electrocardiographic waveform analysis for predicting the success of defibrillation. Crit Care Med. 2000 Nov;28(11 Suppl):N210-1.

Callaway CW, Sherman LD, Scheatzle MD, Menegazzi JJ. Scaling structure of electrocardiographic waveform during prolonged ventricular fibrillation in swine. Pacing Clin Electrophysiol. 2000 Feb;23(2):180-91.

Patwardhan A, Moghe S, Wang K, Cruise H, Leonelli F. Relation between ventricular fibrillation voltage and probability of defibrillation shocks. Analysis using Hilbert transforms. J Electrocardiol. 1998 Oct;31(4):317-25.

Neurauter A, Strohmenger HU. Prediction of countershock success employing single features from multiple ventricular fibrillation frequency bands and feature combinations using neural networks. Resuscitation. 2008 Jan;76(1):152. Epub 2007 Aug 13.

Sherman LD, Niemann JT, Rosborough JP, Menegazzi JJ. The effect of ischemia on ventricular fibrillation as measured by fractal dimension and frequency measures. Resuscitation. 2007 Dec;75(3):499-505. Epub 2007 Jul 13.

Huizar JF, Warren MD, Shvedko AG, Kalifa J, Moreno J, Mironov S, Jalife J, Zaitsev AV. Three distinct phases of VF during global ischemia in the isolated blood-perfused pig heart. Am J Physiol Heart Circ Physiol. 2007 Sep;293(3):H1617-28. Epub 2007 Jun 1.

Neurauter A, Kramer-Johansen J, Eilevstjønn J, Myklebust H, Wenzel V, Lindner KH, Eftestøl T, Steen PA, Strohmenger HU. Estimation of the duration of ventricular fibrillation using ECG single feature analysis. Resuscitation. 2007 May;73(2):246-52. Epub 2007 Mar 21.

Indik JH, Donnerstein RL, Berg RA, Hilwig RW, Berg MD, Kern KB. Ventricular fibrillation frequency characteristics are altered in acute myocardial infarction. Crit Care Med. 2007 Apr;35(4):1133-8.

Chorro FJ, Guerrero J, Trapero I, Such-Miquel L, Mainar L, Cánoves J, Blasco E, Ferrero A, Sanchís J, Bodí V, Such L. [Time-frequency analysis of ventricular fibrillation. An experimental study]. Rev Esp Cardiol. 2006 Sep;59(9):869-78. Spanish.

Indik JH, Donnerstein RL, Kern KB, Goldman S, Gaballa MA, Berg RA. Ventricular fibrillation waveform characteristics are different in ischemic heart failure compared with structurally normal hearts. Resuscitation. 2006 Jun;69(3):471-7. Epub 2006 Apr 4.

Callihan J, Roeder R, Geddes LA, Otlewski M, Kemeny A. Ventricular fibrillation frequency. Pacing Clin Electrophysiol. 2005 Jul;28(7):610-2.

Moreno J, Zaitsev AV, Warren M, Berenfeld O, Kalifa J, Lucca E, Mironov S, Guha P, Jalife J. Effect of remodelling, stretch and ischaemia on ventricular fibrillation frequency and dynamics in a heart failure model. Cardiovasc Res. 2005 Jan 1;65(1):158-66.

Watson JN, Uchaipichat N, Addison PS, Clegg GR, Robertson CE, Eftestol T, Steen PA. Improved prediction of defibrillation success for out-of-hospital VF cardiac arrest using wavelet transform methods. Resuscitation. 2004 Dec;63(3):269-75.

Young C, Bisera J, Gehman S, Snyder D, Tang W, Weil MH. Amplitude spectrum area: measuring the probability of successful defibrillation as applied to human data. Crit Care Med. 2004 Sep;32(9 Suppl):S356-8.

Indik JH, Donnerstein RL, Berg MD, Samson RA, Berg RA. Ventricular fibrillation frequency characteristics and time evolution in piglets: a developmental study. Resuscitation. 2004 Oct;63(1):85-92.

Goto Y, Suzuki I, Inaba H. Frequency of ventricular fibrillation as predictor of one-year survival from out-of-hospital cardiac arrests. Am J Cardiol. 2003 Aug 15;92(4):457-9.

Kolarova J, Ayoub IM, Yi Z, Gazmuri RJ. Optimal timing for electrical defibrillation after prolonged untreated ventricular fibrillation. Crit Care Med. 2003 Jul;31(7):2022-8.

Amann A, Rheinberger K, Achleitner U, Krismer AC, Lingnau W, Lindner KH, Wenzel V. The prediction of defibrillation outcome using a new combination of mean frequency and amplitude in porcine models of cardiac arrest. Anesth Analg. 2002 Sep;95(3):716-22, table of contents.

Waalewijn RA, Nijpels MA, Tijssen JG, Koster RW. Prevention of deterioration of ventricular fibrillation by basic life support during out-of-hospital cardiac arrest. Resuscitation. 2002 Jul;54(1):31-6.

Povoas HP, Weil MH, Tang W, Bisera J, Klouche K, Barbatsis A. Predicting the success of defibrillation by electrocardiographic analysis. Resuscitation. 2002 Apr;53(1):77-82.

Valderrábano M, Yang J, Omichi C, Kil J, Lamp ST, Qu Z, Lin SF, Karagueuzian HS, Garfinkel A, Chen PS, Weiss JN. Frequency analysis of ventricular fibrillation in Swine ventricles. Circ Res. 2002 Feb 8;90(2):213-22.

Marn-Pernat A, Weil MH, Tang W, Pernat A, Bisera J. Optimizing timing of ventricular defibrillation. Crit Care Med. 2001 Dec;29(12):2360-5.

Strohmenger HU, Eftestol T, Sunde K, Wenzel V, Mair M, Ulmer H, Lindner KH, Steen PA. The predictive value of ventricular fibrillation electrocardiogram signal frequency and amplitude variables in patients with out-of-hospital cardiac arrest. Anesth Analg. 2001 Dec;93(6):1428-33, table of contents.

Hamprecht FA, Jost D, Rüttimann M, Calamai F, Kowalski JJ. Preliminary results on the prediction of countershock success with fibrillation power. Resuscitation. 2001 Sep;50(3):297-9.

Hamprecht FA, Achleitner U, Krismer AC, Lindner KH, Wenzel V, Strohmenger HU, Thiel W, van Gunsteren WF, Amann A. Fibrillation power, an alternative method of ECG spectral analysis for prediction of countershock success in a porcine model of ventricular fibrillation. Resuscitation. 2001 Sep;50(3):287-96.

Amann A, Achleitner U, Antretter H, Bonatti JO, Krismer AC, Lindner KH, Rieder J, Wenzel V, Voelckel WG, Strohmenger HU. Analysing ventricular fibrillation ECG-signals and predicting defibrillation success during cardiopulmonary resuscitation employing N(alpha)-histograms. Resuscitation. 2001 Jul;50(1):77-85.

Achleitner U, Wenzel V, Strohmenger HU, Lindner KH, Baubin MA, Krismer AC, Mayr VD, Amann A. The beneficial effect of basic life support on ventricular fibrillation mean frequency and coronary perfusion pressure. Resuscitation. 2001 Nov;51(2):151-8.

Amann A, Rheinberger K, Achleitner U. Algorithms to analyze ventricular fibrillation signals. Curr Opin Crit Care. 2001 Jun;7(3):152-6. Review.

Lightfoot CB, Sorensen TJ, Garfinkel MD, Sherman LD, Callaway CW, Menegazzi JJ. Physician interpretation and quantitative measures of electrocardiographic ventricular fibrillation waveform. Prehosp Emerg Care. 2001 Apr-Jun;5(2):147-54.

Jones JL, Tovar OH. Electrophysiology of ventricular fibrillation and defibrillation. Crit Care Med. 2000 Nov;28(11 Suppl):N219-21. Review.

Eftestol T, Sunde K, Ole Aase S, Husoy JH, Steen PA. Predicting outcome of defibrillation by spectral characterization and nonparametric classification of ventricular fibrillation in patients with out-of-hospital cardiac arrest. Circulation. 2000 Sep 26;102(13):1523-9.

Patwardhan A, Moghe S, Wang K, Leonelli F. Frequency modulation within electrocardiograms during ventricular fibrillation. Am J Physiol Heart Circ Physiol. 2000 Aug;279(2):H825-35.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Freese JP, Jorgenson DB, Liu PY, Innes J, Matallana L, Nammi K, Donohoe RT, Whitbread M, Silverman RA, Prezant DJ. Waveform analysis-guided treatment versus a standard shock-first protocol for the treatment of out-of-hospital cardiac arrest presenting in ventricular fibrillation: results of an international randomized, controlled trial. Circulation. 2013 Aug 27;128(9):995-1002. doi: 10.1161/CIRCULATIONAHA.113.003273.


Responsible Party:	John Freese, M.D., New York City Fire Department
ClinicalTrials.gov Identifier:	NCT00535106 History of Changes
Other Study ID Numbers:	H05290
Study First Received:	September 25, 2007
Last Updated:	October 18, 2009
Health Authority:	United States: Federal Government

Keywords provided by New York City Fire Department:


Ventricular fibrillation Cardiac arrest Automated external defibrillator	AED Waveform based algorithms VF waveform analysis

Additional relevant MeSH terms:


Ventricular Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015

To Top