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

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ClinicalTrials.gov Identifier: NCT00650962
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

March 30, 2008
April 2, 2008
January 5, 2012
February 2008
December 2009   (Final data collection date for primary outcome measure)
Sustained ROSC >= 2 hours [ Time Frame: 180 days ]
ROSC rate and survival to admission / discharge / 180 days. CPC level at every time points. [ Time Frame: 180 days ]
Complete list of historical versions of study NCT00650962 on ClinicalTrials.gov Archive Site
  • surival to ICU admission [ Time Frame: 180 days ]
  • survival to hospital discharge [ Time Frame: 180 days ]
  • Rates of good neurology recovery (CPC 1 &2) [ Time Frame: 180 days ]
Not Provided
Not Provided
Not Provided
 
Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial
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.
  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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiac Arrest
  • Other: cardiopulmonary resuscitation
    10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
    Other Name: automatic external defibrillator
  • Other: Rhythm analysis
    Rhythm analysis as soon as AED is ready
    Other Names:
    • cardiopulmonary resuscitation
    • automatic external defibrillator
  • Active Comparator: CPR first
    Compression First (CF)
    Intervention: Other: cardiopulmonary resuscitation
  • Active Comparator: Analysis First
    Rhythm analysis first
    Intervention: Other: Rhythm analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1666
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00650962
200710019R
NSC 962314B002018
Yes
Not Provided
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: Matthew Huei-Ming Ma, MD, PHD Department of Emergency Medicine, NTUH.
National Taiwan University Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP