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 FDA-approved 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 mmH2O. 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
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the emergency medical service crew will know the intervention in each participant. The patient will not be aware of the type of ventilation strategy because of OHCA status. The investigator and outcomes assessor will not able to acquire the allocation results until the study ends.
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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chest compression depth in the prehospital resuscitation | up to 1 hour | The chest compression depth recorded by the portable monitor with feedback pad. |
| Chest compression rate in the prehospital resuscitation | up to 1 hour | The chest compression rate recorded by the portable monitor with feedback pad. |
| End-tidal carbon dioxide level (ETCO2) | 1 hour | The ETCO2 recorded in the prehospital resuscitation process. |
| Ventilation rate in the prehospital resuscitation | up to 1 hour | The ventilation rate recorded by the portable monitor with feedback sensor (BVM help). |
| Tidal volume in the prehospital resuscitation | up to 1 hour | The tidal volume recorded by the portable monitor with feedback sensor (BVM help). |
Countries
Taiwan
Contacts
Primary ContactCheng Yi Fan, M.D.
Outcome results
None listed