Cardiopulmonary Resuscitation Performance of Professional Rescuers With a New Defibrillation Algorithm (DEFI-2022)

Professional Rescuers Cardiopulmonary Resuscitation Performance After Implementation of a Defibrillation Algorithm for Early Treatment of Refibrillation, an Observational Study.

In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease.

On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion.

The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred

The aim of the study

Study Design:

This is a prospective observational study.

The eligibility criteria are as follows:

• Patients in Out-Of-Hospital Cardiac Arrest.
• Basic Life support care with an AED.

The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Sudden Cardiac Death; Cardiac Arrest, Sudden

Detailed Description

BACKGROUND

For Out-Of-Hospital Cardiac Arrest (OHCA) patients suffering from ventricular fibrillation (VF) or ventricular tachycardia (VT), BLS care consists of administering external electric shocks (EES) and cardiopulmonary resuscitation (CPR). However, despite successful defibrillation, VF recurs in 50% of cases. Rescuers are forced to repeat EES as often as needed, without the recommendations specifying a maximum number.

International guidelines recommend a 2-min CPR time between 2 rhythm analysis, that means one shock every 2 min. Since refibrillation occurs mostly during the first-minute post-shock, the patient will have to wait until the end of the 2 minutes before receiving the next EES. During that time, the chest compressions (CC) provide a reduced fraction of physiologic blood flow.

The new AED algorithm provides the following changes :

• After a 60-second post-shock CPR-period, the AED performs an analysis "in presence of CC" i.e., without CC interruption is performed.
• Each time the AED detects a VF "in presence of CC" the algorithm requires the CC to be interrupted to perform an analysis "in absence of CC " to confirm the rhythm shockability.
• Analyses "in presence of CC" are triggered every minute, possibly followed or not by an analysis " in absence of CC "
• at least, the algorithm performs an analysis " in absence of CC " systematically every 2 minutes.

This new algorithm fits in between two historical CPR algorithms used in western medical systems - the one-minute and the two-minute CPR cycle- depending on the rhythm shockability detected " in presence of CC "

OBJECTIVES

The main objective is to measure the " CC fraction " during the ten first minutes of Fire Fighter BLS care in OHCA.

The secondary objectives :

1. Report on the available CPR quality parameters (CC frequency, hands-off maximum).
2. Report on the AED's diagnostic performance when analyzing the rhythm "in presence of CC "
3. Report on the AED's diagnostic performance when analyzing the rhythm " in absence of CC "
4. Report on the overall AED's diagnostic performance that results from the combination of two consecutive analyses " in presence of CC " and " in absence of CC"
5. Report on post-shock rhythms and their incidence
6. Report on the number of EES per patient
7. Report on the time distribution for the shocks administered per-patient to describe the rhythmic storm.
8. Report on the incidence of Return Of Spontaneous Circulation (ROSC), survival at hospital admission, and survival at hospital discharge.
9. Compare these reports to a historical cohort (2017).

METHOD

This is a prospective observational study.

• The observation window is limited to CPR cycles within the first 10 minutes of BLS care, or less if ROSC is presumed.
• The choice of 10 minutes is intended to observe the BLS team's action, without interfering with the ALS team that arrives later.
• The three following criteria define a presumptive ROSC:
• 1. presence of QRS complexes of broadly similar morphology
• 2. synchronous impedance curve variation with the QRS complexes (indicating intrathoracic movement, in that case, cardiac mechanical activity)
• 3. no on-going CC
• A CPR cycle is defined by the delay between two " in absence of CC " analyses.

The study does not imply any change in current practice. There is no planned interim analysis.

All consecutive participants with inclusion criteria and no exclusion criteria will be analyzed.

STUDY SIZE

A study size for a before-after comparison, with 2017 as the "before" period and 2020 as the "after" period has been calculated

In our healthcare system, the average CC fraction was 65% in 2017, whereas the ERC guidelines recommend a minimum of 60%.

With the use of the 2020 algorithm, for CA with shockable rhythm, the CC fraction is expected to decrease slightly, as the analyses become closer in time.

It is assumed a CCfraction in 2020 being " equivalent " to 2017 (65%) and consider that a difference in CCfraction rate as large as 10% in favor of the 2017 period still allows the new algorithm to be non-inferior (delta = 0.1). The sample size calculation is based on an 80% power to confirm non-inferiority and a one-sided confidence level of 97.5%.

As a result, the number of subjects to be included in each period is 285.

Note that this same number of patients will be sufficient to detect an absolute 10% difference with an alpha risk of 5% and a power of 90%, between patients in the "2017" group and patients in the "2020" group with regard to the secondary endpoint "Survival at hospital admission"

INTERRUPTION OR STOPPING OF THE STUDY

The sponsor has the responsibility to report, to the national health authority, any serious and unexpected adverse events attributable to the new AED algorithm.

RISKS

A full report on the risks, the description of incidents, accidents and adverse events will be the subject of a chapter in the results section and also in the discussion.

FINANCING

Funding for the study is provided by the Paris Fire Brigade (promoter, following acceptance of the survey under French policy for clinical research projects)

DISCUSSION

The study will report on the CC fraction of an AED algorithm designed to analyze "under CC."

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

Study Locations

• France
  • Non, Merci
    • Paris, Non, Merci, France, 75017
      • Paris Fire Brigade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical OHCA patients of the greater Paris (Paris, Haut-de-Seine, Seine-Saint-Denis and Val- de-Marne Country)

Description

Inclusion Criteria:

-Non-traumatic OHCA in adults, treated by a BLS team and connected to an AED equipped either with the 2017 or with the 2020 algorithm.

Exclusion Criteria:

• Use of AED in a pediatric mode
• CPR administered in 15:2 mode
• Patient already connected to another defibrillator at the arrival of the BLS Team
• No shock advised by defibrillator at first analysis
• Patient with a pacemaker

Secondary Exclusion Criteria

• Surviving patients' opposition to the use of their data.
• Patients with unreadable electrocardiographic or impedance data.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report on Chest Compression Fraction (CCf)	CCf is the length of time the patient receives chest compression/management time (describe as a %)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report on Cardiopulmonary Resuscitation (CPR) parameters : CPR ratio	CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %)	10 minutes
Report on Cardiopulmonary Resuscitation (CPR) parameters :Prompt CPR fraction	Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %)	10 minutes
Report on Cardiopulmonary Resuscitation (CPR) parameters:Maximal Hands-Off time	Maximal Hands-Off time (longest time frame without any CC; describe in seconds)	10 minutes
Report on Cardiopulmonary Resuscitation (CPR) parameters:Chest Compression Frequency	Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute)	10 minutes
Report on the diagnostic performance of the AED algorithms "during CC" and " in absence of CC"	Calculate Sensibility and Specificity	10 minutes
Report on the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC"	Calculate Sensibility and Specificity	10 minutes
Report on five-second-post-shock rhythms and their incidence	asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 5 seconds	10 minutes
Report on 60-second-post-shock rhythms and their incidence	asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 60 seconds	10 minutes
Report on 120 second-post-shock rhythms and their incidence	asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 120 seconds	10 minutes
Report on 15-second-post-shock rhythms and their incidence	asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 15 seconds	10 minutes
Report on 30-second-post-shock rhythms and their incidence	asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 30 seconds	10 minutes
Report on the number of electrical shocks (EES) delivered and the duration of the rhythmic storm	Total number of EES delivered (describe as a number)	1 hour
Report on the number of electrical shocks (EES) intended and the duration of the rhythmic storm	Ratio "number of EES intended / number of EES delivered" (describe as a ratio %)	1 hour
Report on the temporal distribution of electrical shocks (EES) and the duration of the rhythmic storm	EES temporal distribution per patient	1 hour
Report on the delay from start to end of cumulative VF episodes	The time period from the start of the first occurence of VF to to the ending of the last episode of ventricular fibrillation (VF) ( seconds)	1 hour
The time period from the AED-switch-on and the first EES (describe in seconds)	The time period from the AED-switch-on and the first EES (describe in seconds)	1 hour
The distribution over time of EES.	The distribution over time of EES.	1 hour
Outcomes - ROSC	Return Of Spontaneous Circulation (ROSC) (describe as a ratio of patients with ROSC / patients included)	2 hours
Outcomes - admitted alive at hospital	Survival to hospital admission (describe as a ratio of patients admitted beating heart to hospital / patients included)	2 hours
Outcomes - discharged from hospital	Survival at hospital discharge (describe as a ratio of patients discharged alive from hospital / patients included)	1 month
Compare Chest Compression Fraction (CCf) to Paris Fire Brigade 2017 historical data	CCf is the length of time the patient receives chest compression/management time (describe as a %)	10 minutes
Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %)	Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %)	10 minutes
CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %)	CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %)	10 minutes
Maximal Hands-Off time (longest time frame without any CC; describe in seconds)	Maximal Hands-Off time (longest time frame without any CC; describe in seconds)	10 minutes
Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute)	Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute)	10 minutes
Compare Sensibility and Specificity of AED algorithm "during CC" and "in absence of CC" to 2017 algorithm Sensibility and Specificity	Compare Sensibility and Specificity of AED algorithm "during CC" and "in absence of CC" to 2017 algorithm Sensibility and Specificity	10 minutes
Compare the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC" to Paris Fire Brigade 2017 historical data	Compare the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC" to Paris Fire Brigade 2017 algorithm Sensibility and Specificity	10 minutes
Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data	Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in presence of CC" analysis, at 5 seconds to Paris Fire Brigade 2017 differents rhythms incidences.	10 minutes
Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data	Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 60 seconds to Paris Fire Brigade 2017 differents rhythms incidences.	10 minutes
Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data	Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 120 seconds to Paris Fire Brigade 2017 differents rhythms incidences.	10 minutes
Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data	Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 5 seconds to Paris Fire Brigade 2017 differents rhythms incidences.	10 minutes
Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data	Total number of EES delivered (describe as a number) compare to Paris Fire Brigade 2017 historical data	10 minutes
Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data	EES temporal distribution per patient compare to Paris Fire Brigade 2017 historical data	10 minutes
Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data	The time period from the start of the first to the end of the last ventricular fibrillation (VF) episode (describe in seconds) compare to Paris Fire Brigade 2017 historical data	10 minutes
Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data	The time period from the AED-switch-on and the first EES (describe in seconds) compare to Paris Fire Brigade 2017 historical data	10 minutes
Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data	Compare the distribution over time of EES.to Paris Fire Brigade 2017 historical data	10 minutes
Outcomes - ROSC	Compare return Of Spontaneous Circulation (ROSC) to Paris Fire Brigade 2017 historical data (describe as a ratio of patients with ROSC / patients included)	1 hour
Outcomes - admitted alive at hospital	Compare survival to hospital admission to Paris Fire Brigade 2017 historical data (describe as a ratio of patients admitted beating heart to hospital / patients included)	2 hours
Outcomes - hospital discharge	Compare survival at hospital discharge to Paris Fire Brigade 2017 historical data (describe as a ratio of patients discharged alive from hospital / patients included)	1 month

Collaborators and Investigators

• Sponsor: French Defence Health Service
• Investigators: Principal Investigator: Clément DERKENNE, MD, Paris Fire Brigade

Publications and helpful links

General Publications

• 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. doi: 10.1056/NEJMoa020932.
• Baker PW, Conway J, Cotton C, Ashby DT, Smyth J, Woodman RJ, Grantham H; Clinical Investigators. Defibrillation or cardiopulmonary resuscitation first for patients with out-of-hospital cardiac arrests found by paramedics to be in ventricular fibrillation? A randomised control trial. Resuscitation. 2008 Dec;79(3):424-31. doi: 10.1016/j.resuscitation.2008.07.017. Epub 2008 Nov 4.
• Berdowski J, ten Haaf M, Tijssen JG, Chapman FW, Koster RW. Time in recurrent ventricular fibrillation and survival after out-of-hospital cardiac arrest. Circulation. 2010 Sep 14;122(11):1101-8. doi: 10.1161/CIRCULATIONAHA.110.958173. Epub 2010 Aug 30.
• Berdowski J, Tijssen JG, Koster RW. Chest compressions cause recurrence of ventricular fibrillation after the first successful conversion by defibrillation in out-of-hospital cardiac arrest. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):72-8. doi: 10.1161/CIRCEP.109.902114. Epub 2009 Dec 30.
• Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.
• Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L; Resuscitation Outcomes Consortium (ROC) Investigators. Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation. 2011 Jul 5;124(1):58-66. doi: 10.1161/CIRCULATIONAHA.110.010736. Epub 2011 Jun 20.
• Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.
• Fumagalli F, Silver AE, Tan Q, Zaidi N, Ristagno G. Cardiac rhythm analysis during ongoing cardiopulmonary resuscitation using the Analysis During Compressions with Fast Reconfirmation technology. Heart Rhythm. 2018 Feb;15(2):248-255. doi: 10.1016/j.hrthm.2017.09.003. Epub 2017 Sep 14.
• Gliner BE, White RD. Electrocardiographic evaluation of defibrillation shocks delivered to out-of-hospital sudden cardiac arrest patients. Resuscitation. 1999 Jul;41(2):133-44. doi: 10.1016/s0300-9572(99)00040-4.
• Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.
• Hu Y, Tang H, Liu C, Jing D, Zhu H, Zhang Y, Yu X, Zhang G, Xu J. The performance of a new shock advisory algorithm to reduce interruptions during CPR. Resuscitation. 2019 Oct;143:1-9. doi: 10.1016/j.resuscitation.2019.07.026. Epub 2019 Aug 1.
• Jost D, Degrange H, Verret C, Hersan O, Banville IL, Chapman FW, Lank P, Petit JL, Fuilla C, Migliani R, Carpentier JP; DEFI 2005 Work Group. DEFI 2005: a randomized controlled trial of the effect of automated external defibrillator cardiopulmonary resuscitation protocol on outcome from out-of-hospital cardiac arrest. Circulation. 2010 Apr 13;121(14):1614-22. doi: 10.1161/CIRCULATIONAHA.109.878389. Epub 2010 Mar 29.
• Kerber RE, Becker LB, Bourland JD, Cummins RO, Hallstrom AP, Michos MB, Nichol G, Ornato JP, Thies WH, White RD, Zuckerman BD. Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997 Mar 18;95(6):1677-82. doi: 10.1161/01.cir.95.6.1677.
• Krasteva V, Jekova I, Dotsinsky I, Didon JP. Shock advisory system for heart rhythm analysis during cardiopulmonary resuscitation using a single ECG input of automated external defibrillators. Ann Biomed Eng. 2010 Apr;38(4):1326-36. doi: 10.1007/s10439-009-9885-9. Epub 2010 Jan 13.
• Roh YI, Jung WJ, Hwang SO, Kim S, Kim HS, Kim JH, Kim TY, Kang HS, Lee JS, Cha KC. Shorter defibrillation interval promotes successful defibrillation and resuscitation outcomes. Resuscitation. 2019 Oct;143:100-105. doi: 10.1016/j.resuscitation.2019.08.022. Epub 2019 Aug 20.
• Vaillancourt C, Everson-Stewart S, Christenson J, Andrusiek D, Powell J, Nichol G, Cheskes S, Aufderheide TP, Berg R, Stiell IG; Resuscitation Outcomes Consortium Investigators. The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation. Resuscitation. 2011 Dec;82(12):1501-7. doi: 10.1016/j.resuscitation.2011.07.011. Epub 2011 Jul 18.
• Affatato R, Li Y, Ristagno G. See through ECG technology during cardiopulmonary resuscitation to analyze rhythm and predict defibrillation outcome. Curr Opin Crit Care. 2016 Jun;22(3):199-205. doi: 10.1097/MCC.0000000000000297.
• van Alem AP, Post J, Koster RW. VF recurrence: characteristics and patient outcome in out-of-hospital cardiac arrest. Resuscitation. 2003 Nov;59(2):181-8. doi: 10.1016/s0300-9572(03)00208-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): April 2, 2022

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Arrest; Automatic External Defibrillator; Chest Compression Fraction; Electrical Cardiac Analysis under Chest Compressions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Death; Heart Arrest; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac
• Other Study ID Numbers: DEFI 2022 OBSERVATIONAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No