Clinical trial NCT00650962: Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: CPR
Preshock CPR
OHCA
EMS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2008-04-02
Enrollment: 1666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Sustained ROSC >= 2 hours
timeFrame: 180 days
Secondary outcomes:
measure: surival to ICU admission
timeFrame: 180 days
measure: survival to hospital discharge
timeFrame: 180 days
measure: Rates of good neurology recovery (CPC 1 &2)
timeFrame: 180 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Emergency Medicine, National Taiwan University Hospital
Study officials:
affiliation: Department of Emergency Medicine, NTUH.
name: Matthew Huei-Ming Ma, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: