Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial (CPR)
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cardiopulmonary resuscitation
Rhythm analysis
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring CPR, Preshock CPR, OHCA, EMS
Eligibility 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.
Sites / Locations
- Department of Emergency Medicine, National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CPR first
Analysis First
Arm Description
Compression First (CF)
Rhythm analysis first
Outcomes
Primary Outcome Measures
Sustained ROSC >= 2 hours
Secondary Outcome Measures
surival to ICU admission
survival to hospital discharge
Rates of good neurology recovery (CPC 1 &2)
Full Information
NCT ID
NCT00650962
First Posted
March 30, 2008
Last Updated
January 2, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00650962
Brief Title
Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial
Acronym
CPR
Official Title
Does Longer Pre-shock Cardiopulmonary Resuscitation Improve the Outcome of Patients With Out-of-hospital Cardiac Arrest? A Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
Detailed Description
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.
Response time in Taipei emergency medical service was longer than 5 minutes.
Bystander cardiopulmonary resuscitation rate were relatively low in Taipei.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
CPR, Preshock CPR, OHCA, EMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1666 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPR first
Arm Type
Active Comparator
Arm Description
Compression First (CF)
Arm Title
Analysis First
Arm Type
Active Comparator
Arm Description
Rhythm analysis first
Intervention Type
Other
Intervention Name(s)
cardiopulmonary resuscitation
Other Intervention Name(s)
automatic external defibrillator
Intervention Description
10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
Intervention Type
Other
Intervention Name(s)
Rhythm analysis
Other Intervention Name(s)
cardiopulmonary resuscitation, automatic external defibrillator
Intervention Description
Rhythm analysis as soon as AED is ready
Primary Outcome Measure Information:
Title
Sustained ROSC >= 2 hours
Time Frame
180 days
Secondary Outcome Measure Information:
Title
surival to ICU admission
Time Frame
180 days
Title
survival to hospital discharge
Time Frame
180 days
Title
Rates of good neurology recovery (CPC 1 &2)
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Huei-Ming Ma, MD, PHD
Organizational Affiliation
Department of Emergency Medicine, NTUH.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Emergency Medicine, National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial
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