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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Singapore General Hospital
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
Ong Eng Hock Marcus, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01665755
First received: August 6, 2012
Last updated: August 10, 2014
Last verified: August 2014
History of Changes
  Purpose

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 Intervention Phase
Cardiac Event
Sudden Cardiac Death
Death
Ventricular Fibrillation
Ventricular Tachycardia
 Device: Upstroke Compression Defibrillation
Device: Precompression Defibrillation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • successful electrical conversion (shock success) [ Time Frame: establishment of organized rhythm within 60 seconds ] [ Designated as safety issue: No ]
    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:
  • termination of VF regardless of the resulting rhythm [ Time Frame: at least 5 seconds after the shock ] [ Designated as safety issue: No ]
  • Return of spontaneous circulation (ROSC) [ Designated as safety issue: No ]
  • Survival to hospital admission [ Designated as safety issue: No ]
  • Survival to hospital discharge [ Designated as safety issue: No ]
  • Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC) [ Designated as safety issue: No ]
  • European Quality of Life in 5 Dimensions [ Designated as safety issue: No ]
Estimated Enrollment: 288
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Precompression Device: Precompression Defibrillation
Active Comparator: Upstroke Compression Device: Upstroke Compression Defibrillation

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.
  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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: NCT01665755

Contacts
Contact: Marcus Eng Hock Ong, MBBS, FRCS +65 6321 3590 marcus.ong.e.h@sgh.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

No publications provided

Responsible Party: Ong Eng Hock Marcus, Senior Consultant, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01665755     History of Changes
Other Study ID Numbers: 2011/456/C
Study First Received: August 6, 2012
Last Updated: August 10, 2014
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Death
 Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes
Tachycardia

ClinicalTrials.gov processed this record on March 03, 2015