Out-Of-Hospital Cardiac Arrest
Conditions
Keywords
automatic ventilation, prehospital resuscitation, emergency medical service
Brief summary
The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are: 1. How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation. 2. What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.
Interventions
DEVICEAutomatic ventilation
The device used is "Meditech" MICROVENT RESUSCITATOR, which is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. It is powered by the airflow from the oxygen tank and provides ventilation in fixed interval. It has a pressure valve which will release the pressure once the airway pressure exceeds its threshold. In the current study, the threshold is set at 60 cmH2O. The tidal volume is set at 500-600 ml.
DEVICEManual ventilation
The adult size bag-valve mask is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. The interval, pressure and volume of the ventilation is controlled by the emergency medical technicians.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster randomised crossover trial. The unit of randomisation is the EMS team-period: each of 13 advanced life support EMS teams of the Hsinchu County Fire Bureau was assigned, in consecutive 14-day periods starting at 08:00 on Mondays, to automated pneumatic ventilation (APV) or manual bag-valve-mask ventilation (BVM) according to a computer-generated blocked sequence (block size 6, 1:1 allocation). Teams therefore switched repeatedly between the two strategies, and teams joined the trial in a staggered manner. All eligible patients treated by a team during a period received the ventilation strategy allocated to that team-period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (OHCA). * Attended by the Hsinchu County Fire Department for emergency medical assistance.
Exclusion criteria
* Pregnant women. * OHCA caused by trauma. * Return of spontaneous circulation (ROSC) observed at the scene. * Clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture). * Refusal of medical transportation by family members. * No placement of an advanced airway throughout the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of any return of spontaneous circulation (ROSC) | 2 hours | The patient achieved ROSC in prehospital or inhospital resuscitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of sustained ROSC in 24 hours | up to 24 hours | The patient survives for 24 hours after arriving the hospital. |
| The percentage of survival to hospital discharge | up to 90 days | The patient survives to discharge from the hospital. |
| The percentage of favorable neurological outcome after discharge | up to 90 days | The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2. |
| Chest compression fraction | up to 1 hour | The chest compression fraction during prehospital resuscitation recorded by the monitor. |
| The percentage of intravenous catheter placement | up to 1 hour | Whether the patient has an IV catheter placed in the prehospital setting. |
| The percentage of epinephrine injection | up to 1 hour | Whether the patient has epinephrine injected in the prehospital setting. |
| The satisfaction of emergency medical technician (EMT) during the dispatch | up to 5 hours | The outcome contained five questions: * More convenient to use * Shorter time required to complete ventilation (from advanced airway placement to the start of ventilation) * Smoother patient transport process * Ability to perform more emergency medical techniques * Overall satisfaction with the execution of emergency medical tasks The EMTs answer in the 5-level scale (highly disagree, disagree, neutral, agree, highly agree) |
| The percentage of pneumothorax | up to 3 days | Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy. |
Countries
Taiwan
Contacts
STUDY_CHAIREdward Pei-Chuan Huang, M.D., M.S.
National Taiwan University Hospital
Outcome results
None listed