AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute" (DEFI2005)

May 8, 2009 updated by: Fire Brigade Of Paris Emergency Medicine Dept

Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock, and the time devoted to chest compressions.

The researchers propose to decrease the periods of interruption of cardiopulmonary resuscitation (CPR), while keeping the principle of early defibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early use of semi-automated external defibrillators (AED) by Emergency Care teams in out-of-hospital cardiac arrest (OHCA), has been correlated with a significant gain in sequelae-free survival. The AED is programmed with an algorithm based recommended guidelines.

We will test a new algorithm that takes into account recent findings in pathophysiology.

Patients presenting with cardiovascular and pulmonary arrest treated by the BSPP Emergency Care who meet inclusion criterion are proposed for inclusion in the trial.

The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock, and the time devoted to chest compressions.

The new algorithm is entitled "one shock per minute". Use of this algorithm should validate several hypotheses:

  • the importance of administering cardiac massage and artificial ventilation (CPR) prior to initiation of electrical shock treatment.
  • the importance of continuing CPR immediately following electrical shock treatment
  • the importance of reducing time between CPR procedures to a minimum
  • the fact that three successive electrical shocks are of no therapeutic benefit.

We want to compare the control algorithm with the new one titled "one shock per minute", for shocked patients.

The sample size of this trial was calculated to provide a power of 85% and a type 1 error rate of alpha = 0.0294 for detecting an 11% increase in the rate of hospital admission, from its historical rate of 34% to a new rate of 45%. One interim analysis was planned with the stopping boundary alpha = 0.0294. This required inclusion of 430 patients in each group.

The primary endpoint is defined as "the admission of the patient alive at the hospital".

The secondary endpoints are defined as following :

- Detection of Palpable Carotid Pulse (ROSC) within the first 8 minutes after the connection of the AED The other secondary endpoint is survival to one year.

Concerning patients that do not receive shocks

They represent a priori 82% of the patients. The absolute number is a priori 3940, that is to say, 1970 in both two groups.

They will be used for an advanced observational descriptive study, to establish hypothesis for future studies.The same primary and secondary endpoints will be evaluated for them.

Among these patients not shocked, the algorithm foresees 60 seconds of CPR for the Control Group, and 90 seconds for the Trial Group. This setting relies on the hypothesis that increasing the time dedicated to chest compressions will increase the probability of return of a palpable pulse (ROSC), even for patients who do not fibrillate.

Statistical analysis will be completed by "Hôpital d'Instruction des Armées BEGIN - Epidemiology department"

We propose a comparison using the Chi square test for qualitative variables, Student's t test for quantitative variables, completion of a logistics model to analyze prognostic factors, as well as the proportional hazards model for survival analysis. Tests will be bilateral (significant p = 0,029 if we consider one intermediate analysis).

Overall analysis strategy will be defined and completed by the Epidemiology department of Hôpital d'Instruction des Armées BEGIN

Study Type

Interventional

Enrollment (Actual)

5107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75017
        • Fire Brigade of Paris Emergency medicine department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in a state of apparent death as noted on arrival of the emergency care team vehicle
  • Resuscitation by first aid team with a minimum of three people
  • Analysis of cardiac rhythm by the AED possible
  • At least one appropriate shock delivered by the AED

Exclusion Criteria:

  • Many victims (>3) that must be treated simultaneously
  • Signs of certain death (lividity)
  • Patient with palpable pulse on arrival of emergency care team
  • Patient already connected to another device
  • Incident involving an AED that requires a "materiovigilance" report

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONTROL
AED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation.
Other: Guidelines 2000 AED protocol
Up to 3 consecutive shocks in a stack; No initial CPR prior to the first shock; Post-shock pulse checks after each non-shockable rhythm analysis; 60 sec CPR after each non-shockable rhythm analysis.
Other Names:
  • Biphasic LIFEPAK(R) 500 AED with cprMAX technology
Experimental: STUDY
AED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks.
Other: One shock per minute AED protocol
Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
Other Names:
  • Biphasic LIFEPAK(R) 500 AED with cprMAX technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of patients appropriately shocked by AED admitted alive at hospital / the total number of patients appropriately shocked by AED
Time Frame: within the first day after the first cardiac arrest
within the first day after the first cardiac arrest

Secondary Outcome Measures

Outcome Measure
Time Frame
Concerning patients appropriately shocked by AED: - return of spontaneous circulation (ROSC) at the arrival of physician on the scene
Time Frame: within the first hour after the first cardiac arrest
within the first hour after the first cardiac arrest
- ROSC within the first 8 minutes after the connection of the AED
Time Frame: within the 8 minutes after the connection of the AED
within the 8 minutes after the connection of the AED
- Patient survival determined throughout the followup period of 1 year post-arrest.
Time Frame: one year after cardiac arrest
one year after cardiac arrest
Safety endpoints were occurrences of CPR-related hemothorax requiring thoracic drain and/or hemorrhagic lesions requiring transfusion
Time Frame: within days of the cardiac arrest
within days of the cardiac arrest
Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED
Time Frame: day of the cardiac arrest
day of the cardiac arrest
- patient admitted alive to the hospital
Time Frame: within 24-48 hours of the cardiac arrest
within 24-48 hours of the cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fire Brigade Of Paris Emergency Medicine Dept

Collaborators

Brigade de Sapeurs Pompiers de Paris
Physio-Control, Inc, A division of Medtronic

Investigators

  • Principal Investigator: Jost Daniel, Doctor, Fire Brigade of Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

May 11, 2009

Last Update Submitted That Met QC Criteria

May 8, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSPP01092005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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