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

NCT01665755 | Completed DMC

• 1 other identifier: 2011/456/C
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  establishment of organized rhythm within 60 seconds

Secondary Outcomes (6)

• termination of VF regardless of the resulting rhythm

  at least 5 seconds after the shock

• Return of spontaneous circulation (ROSC)

  at least 20 minutes

• Survival to hospital admission

  at least 1 day

• Survival to hospital discharge

  at least 1 day

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

  at least 1 day

Study Arms (2)

Precompression

EXPERIMENTAL

Control arm

Device: Precompression Defibrillation

Upstroke Compression

ACTIVE COMPARATOR

Intervention arm

Device: Upstroke Compression Defibrillation

Interventions

Upstroke Compression Defibrillation DEVICE

Upstroke Compression

Precompression Defibrillation DEVICE

Precompression

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac Arrest patients who received eith CPR and/or defibrillation
• Ventricular Fibrillation or Pulseless Ventricular Tachycardia

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Death, Sudden, Cardiac; Death; Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Death, Sudden; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Marcus Eng Hock Ong, MBBS, FRCS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 15, 2012
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 3, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

SG (1)