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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014