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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:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: cardiopulmonary resuscitation Other: Rhythm analysis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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.
Study Start Date : February 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Sustained ROSC >= 2 hours [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. surival to ICU admission [ Time Frame: 180 days ]
  2. survival to hospital discharge [ Time Frame: 180 days ]
  3. Rates of good neurology recovery (CPC 1 &2) [ Time Frame: 180 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00650962     History of Changes
Other Study ID Numbers: 200710019R
NSC 962314B002018
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: December 2011

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