To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
Primary Purpose
Cardiac Event, Sudden Cardiac Death, Death
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Upstroke Compression Defibrillation
Precompression Defibrillation
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Event
Eligibility 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
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Precompression
Upstroke Compression
Arm Description
Control arm
Intervention arm
Outcomes
Primary Outcome Measures
successful electrical conversion (shock success)
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
Return of spontaneous circulation (ROSC)
Survival to hospital admission
Survival to hospital discharge
Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
European Quality of Life in 5 Dimensions
Full Information
NCT ID
NCT01665755
First Posted
August 6, 2012
Last Updated
September 18, 2019
Sponsor
Singapore General Hospital
Collaborators
Zoll Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01665755
Brief Title
To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
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 Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Zoll Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Event, Sudden Cardiac Death, Death, Ventricular Fibrillation, Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Precompression
Arm Type
Experimental
Arm Description
Control arm
Arm Title
Upstroke Compression
Arm Type
Active Comparator
Arm Description
Intervention arm
Intervention Type
Device
Intervention Name(s)
Upstroke Compression Defibrillation
Intervention Type
Device
Intervention Name(s)
Precompression Defibrillation
Primary Outcome Measure Information:
Title
successful electrical conversion (shock success)
Description
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.
Time Frame
establishment of organized rhythm within 60 seconds
Secondary Outcome Measure Information:
Title
termination of VF regardless of the resulting rhythm
Time Frame
at least 5 seconds after the shock
Title
Return of spontaneous circulation (ROSC)
Time Frame
at least 20 minutes
Title
Survival to hospital admission
Time Frame
at least 1 day
Title
Survival to hospital discharge
Time Frame
at least 1 day
Title
Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
Time Frame
at least 1 day
Title
European Quality of Life in 5 Dimensions
Time Frame
at least 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Eng Hock Ong, MBBS, FRCS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
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To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
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