Clinical trial NCT01665755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Event
Sudden Cardiac Death
Death
Ventricular Fibrillation
Ventricular Tachycardia
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2012-08-15
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: successful electrical conversion (shock success)
timeFrame: establishment of organized rhythm within 60 seconds
Secondary outcomes:
measure: termination of VF regardless of the resulting rhythm
timeFrame: at least 5 seconds after the shock
measure: Return of spontaneous circulation (ROSC)
timeFrame: at least 20 minutes
measure: Survival to hospital admission
timeFrame: at least 1 day
measure: Survival to hospital discharge
timeFrame: at least 1 day
measure: Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
timeFrame: at least 1 day
measure: European Quality of Life in 5 Dimensions
timeFrame: at least 1 day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Marcus Eng Hock Ong, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: