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OpenTrials
Completed

NCT Number: NCT01665755

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upstroke Compression Defibrillation

Device

Precompression Defibrillation

Device

Primary outcomes

  1. successful electrical conversion (shock success)

    Time frame: establishment of organized rhythm within 60 seconds

    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 outcomes

  1. termination of VF regardless of the resulting rhythm

    Time frame: at least 5 seconds after the shock

  2. Return of spontaneous circulation (ROSC)

    Time frame: at least 20 minutes

  3. Survival to hospital admission

    Time frame: at least 1 day

  4. Survival to hospital discharge

    Time frame: at least 1 day

  5. Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)

    Time frame: at least 1 day

  6. European Quality of Life in 5 Dimensions

    Time frame: at least 1 day

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Zoll Medical Corporation

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2012
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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