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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: cardiopulmonary resuscitation; Other: Rhythm analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 1666
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Department of Emergency Medicine, National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Matthew Huei-Ming Ma, MD, PHD, Department of Emergency Medicine, NTUH.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: March 30, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (Estimate): April 2, 2008

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 2, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: CPR; EMS; OHCA; Preshock CPR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 200710019R; NSC 962314B002018