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

NCT ID: NCT01665755

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-03

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:

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.

Conditions

Cardiac Event; Sudden Cardiac Death; Death; Ventricular Fibrillation; Ventricular Tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Precompression

Control arm

Group Type: EXPERIMENTAL

Precompression Defibrillation

Intervention Type: DEVICE

Upstroke Compression

Intervention arm

Group Type: ACTIVE_COMPARATOR

Upstroke Compression Defibrillation

Intervention Type: DEVICE

Interventions

Upstroke Compression Defibrillation

Intervention Type: DEVICE

Precompression Defibrillation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoll Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Eng Hock Ong, MBBS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2011/456/C

Identifier Type: -

Identifier Source: org_study_id