Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial

Study Overview
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Brief Summary
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Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's effectiveness in the Asian countries, where most firstly recorded rhythm in out-of-hospital cardiac arrests patients were asystole/pulseless electric activity rather than ventricular fibrillation / ventricular tachycardia, were not explored yet. This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency medical technicians improves the outcome of all out-of-hospital cardiac arrest patients in an Asian metropolitan city.

Detailed Description
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Different from data from the Western countries, non-shockable rhythm (Asystole/pulseless electric activity) was responsible for most out-of-hospital cardiac arrest patients(80% 90%) in metropolitan Taipei. Response time in Taipei emergency medical service was longer than 5 minutes. Bystander cardiopulmonary resuscitation rate were relatively low in Taipei. Cardiopulmonary resuscitation is the only known method to save out-of-hospital cardiac arrest patients with asystole/pulseless electric activity. For those suffered from ventricular fibrillation/ ventricular tachycardia,previous studies revealed pre-shock cardiopulmonary resuscitation may have the potential to improve the outcome. Study hypothesis: Compared with current standard resuscitative sequence (basic life support protocol in Guideline 2005), longer pre-shock cardiopulmonary resuscitation provided to all out-of-hospital cardiac arrest patients in Taipei may improve the outcome of them.

Official Title
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Does Longer Pre-shock Cardiopulmonary Resuscitation Improve the Outcome of Patients With Out-of-hospital Cardiac Arrest? A Randomized Control Trial.

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Other: cardiopulmonary resuscitation
* Other: Rhythm analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with out-of-hospital cardiac arrest Exclusion Criteria: Trauma Age < 18y/o Airway obstruction Submersion Sign of obvious death existing do not resuscitate (DNAR) order family refusal preceding CPR by BLS teams for longer than 2 minutes.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPR first<br>Compression First (CF) | Other: cardiopulmonary resuscitation<br>* 10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED<br>* Other names: automatic external defibrillator;|
| Active Comparator: Analysis First<br>Rhythm analysis first | Other: Rhythm analysis<br>* Rhythm analysis as soon as AED is ready<br>* Other names: automatic external defibrillator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained ROSC >= 2 hours |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surival to ICU admission |  | 180 days | 
| survival to hospital discharge |  | 180 days | 
| Rates of good neurology recovery (CPC 1 &2) |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPR, Preshock CPR, OHCA, EMS