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

Cardiac Arrest Clinical Trial

— CPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650962
• Other study ID #: 200710019R
• Secondary ID: NSC 962314B00201
• Status: Completed
• Phase: N/A
• First received: March 30, 2008
• Last updated: January 2, 2012
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1666
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• cardiopulmonary resuscitation
10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
• Rhythm analysis
Rhythm analysis as soon as AED is ready

Locations

Country	Name	City	State
Taiwan	Department of Emergency Medicine, National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained ROSC >= 2 hours		180 days	No
Secondary	surival to ICU admission		180 days	No
Secondary	survival to hospital discharge		180 days	No
Secondary	Rates of good neurology recovery (CPC 1 &2)		180 days	No