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

NCT ID: NCT00650962

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-12-31

Brief Summary

1. 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.

2. 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

1. 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.

2. Response time in Taipei emergency medical service was longer than 5 minutes.

3. Bystander cardiopulmonary resuscitation rate were relatively low in Taipei.

4. 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.

5. 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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CPR first

Compression First (CF)

Group Type: ACTIVE_COMPARATOR

cardiopulmonary resuscitation

Intervention Type: OTHER

10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED

Analysis First

Rhythm analysis first

Group Type: ACTIVE_COMPARATOR

Rhythm analysis

Intervention Type: OTHER

Rhythm analysis as soon as AED is ready

Interventions

cardiopulmonary resuscitation

10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED

Intervention Type: OTHER

Rhythm analysis

Rhythm analysis as soon as AED is ready

Intervention Type: OTHER

Other Intervention Names

automatic external defibrillator; cardiopulmonary resuscitation; automatic external defibrillator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Huei-Ming Ma, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, NTUH.

Locations

Department of Emergency Medicine, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

NSC 962314B002018

Identifier Type: -

Identifier Source: secondary_id

200710019R

Identifier Type: -

Identifier Source: org_study_id