Cardiopulmonary Resuscitation Performance of Professional Rescuers With a New Defibrillation Algorithm

NCT04691089 | Completed

• 1 other identifier: DEFI 2022 OBSERVATIONAL
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

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))

Conditions

Cardiac Arrest, Sudden; Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death

Keywords

Cardiac Arrest; Automatic External Defibrillator; Chest Compression Fraction; Electrical Cardiac Analysis under Chest Compressions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (39)

• Report on Cardiopulmonary Resuscitation (CPR) parameters : CPR ratio

  10 minutes

• Report on Cardiopulmonary Resuscitation (CPR) parameters :Prompt CPR fraction

  10 minutes

• Report on Cardiopulmonary Resuscitation (CPR) parameters:Maximal Hands-Off time

  10 minutes

• Report on Cardiopulmonary Resuscitation (CPR) parameters:Chest Compression Frequency

  10 minutes

• Report on the diagnostic performance of the AED algorithms "during CC" and " in absence of CC"

  10 minutes

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• French Defence Health Service: lead

Study Sites (1)

Paris Fire Brigade

Paris, Non, Merci, 75017, France

Location

Related Publications (19)

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• 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.

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  PMID: 28917561 BACKGROUND

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  PMID: 26061835 BACKGROUND

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  PMID: 20351239 BACKGROUND

• 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.

  PMID: 9118556 BACKGROUND

• 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.

  PMID: 20069371 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 27031917 RESULT

• 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.

  PMID: 14625108 RESULT

• Didon JP, Jekova I, Frattini B, Menetre S, Derkenne C, Ha VHT, Jost D, Krasteva V. Clinical performance of AED shock advisory system with integrated Analyze Whilst Compressing algorithm for analysis of the ECG rhythm during out-of-hospital cardiopulmonary resuscitation: A secondary analysis of the DEFI 2022 study. Resusc Plus. 2024 Aug 5;19:100740. doi: 10.1016/j.resplu.2024.100740. eCollection 2024 Sep.

  PMID: 39185280 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Study Officials

• Clément DERKENNE, MD

  Paris Fire Brigade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: December 31, 2020
• Study Start: January 18, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 2, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)