To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients

Study Description

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Brief Summary:

In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. The study population will be all cardiac arrest patients attended by the staff of the Emergency Department who fulfil the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest compressions are delivered by an automated device) is prepared. Mechanical CPR should be started as soon as possible (<1 minute). If patients are eligible to be shocked, they will receive shocks either during upstroke of CPR or before CPR is started.

Thus the purpose of this study is to answer the question whether are there improvement in survival between when shocks are given during upstroke and before CPR is started.

Condition or disease	Intervention/treatment	Phase
Cardiac Event; Sudden Cardiac Death; Death; Ventricular Fibrillation; Ventricular Tachycardia	Device: Upstroke Compression Defibrillation; Device: Precompression Defibrillation	Phase 4

Detailed Description:

The purpose of this study will be to compare shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). This will be the world's first study to characterize the phase dependency of defibrillation during mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve clinical outcomes.

The null hypothesis would be that there is no difference in shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). We will conduct statistical comparisons for the primary and secondary outcomes between the arms of the study.

The study population will be all cardiac arrest patients attended by the staff of the ED over the study period who fulfill the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be started as soon as possible (<1 minunte). If a shockable rhythm is present (VF/VT), patients will receive one of pre-randomized defibrillation protocols:

1. Synchronised defibrillation at peak-upstroke
2. Synchronised defibrillation at precompression

Definition of outcomes

• Shock success is defined as the termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
• Survival to hospital discharge is defined as patient surviving the primary event and discharged from the hospital alive.
• Return of spontaneous circulation is defined as the presence of any palpable pulse, which is detected by manual palpation of a major artery.
• Survival to admission is defined as the admission to hospital without ongoing CPR or other artificial circulatory support.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	288 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter Randomised Controlled Trial Comparing Shock Success With Synchronized Defibrillation (Compression Upstroke Versus Precompression) During Ongoing Mechanical Cardiopulmonary Resuscitation In The Emergency Department
Study Start Date :	December 2016
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	June 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Precompression; Control arm	Device: Precompression Defibrillation
Active Comparator: Upstroke Compression; Intervention arm	Device: Upstroke Compression Defibrillation

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. successful electrical conversion (shock success) [ Time Frame: establishment of organized rhythm within 60 seconds ]
   Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.

Secondary Outcome Measures :

1. termination of VF regardless of the resulting rhythm [ Time Frame: at least 5 seconds after the shock ]
2. Return of spontaneous circulation (ROSC) [ Time Frame: at least 20 minutes ]
3. Survival to hospital admission [ Time Frame: at least 1 day ]
4. Survival to hospital discharge [ Time Frame: at least 1 day ]
5. Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC) [ Time Frame: at least 1 day ]
6. European Quality of Life in 5 Dimensions [ Time Frame: at least 1 day ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Cardiac Arrest patients who received eith CPR and/or defibrillation
• Ventricular Fibrillation or Pulseless Ventricular Tachycardia

Exclusion Criteria:

• Patients pronounced dead without attempting CPR according to standard operating procedure and ILCOR guidelines
• Cardiac arrest obviously caused by major trauma
• Children below age 21
• Patients who are pregnant

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Marcus Eng Hock Ong, MBBS, FRCS	+65 6321 3590	marcus.ong.e.h@singhealth.com.sg
Contact: Garion Zhi Xiong Koh, B.Eng Hons	+65 6326 5458	koh.zhi.xiong@sgh.com.sg

Sponsors and Collaborators

Singapore General Hospital

Zoll Medical Corporation

Investigators

Principal Investigator:	Marcus Eng Hock Ong, MBBS, FRCS	Singapore General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT01665755 History of Changes
Other Study ID Numbers:	2011/456/C
First Posted:	August 15, 2012
Last Update Posted:	February 10, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:

Death; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac; Ventricular Fibrillation; Pathologic Processes	Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden