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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00650962
First received: March 30, 2008
Last updated: January 2, 2012
Last verified: December 2011
History of Changes
  Purpose
  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.

Condition Intervention
Cardiac Arrest
 Other: cardiopulmonary resuscitation
Other: Rhythm analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Longer Pre-shock Cardiopulmonary Resuscitation Improve the Outcome of Patients With Out-of-hospital Cardiac Arrest? A Randomized Control Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sustained ROSC >= 2 hours [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surival to ICU admission [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • survival to hospital discharge [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Rates of good neurology recovery (CPC 1 &2) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Enrollment: 1666
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPR first
Compression First (CF)
 Other: cardiopulmonary resuscitation
10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
Other Names:
  • cardiopulmonary resuscitation
  • 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650962

Locations
Taiwan
Department of Emergency Medicine, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Matthew Huei-Ming Ma, MD, PHD Department of Emergency Medicine, NTUH.
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00650962     History of Changes
Other Study ID Numbers: 200710019R, NSC 962314B002018
Study First Received: March 30, 2008
Last Updated: January 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
CPR
Preshock CPR
OHCA
EMS

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013