To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
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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 |
- 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.
- 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: | January 2013 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (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:
- Synchronised defibrillation at peak-upstroke
- 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 |
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| 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 |
| 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: | December 12, 2012 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Additional relevant MeSH terms:
|
Death Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Death, Sudden, Cardiac Pathologic Processes |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Heart Arrest Death, Sudden |
ClinicalTrials.gov processed this record on May 23, 2013