Automatic Ventilation in Prehospital Resuscitation on OHCA

Study Overview
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Brief Summary
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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: How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation. What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.

Official Title
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Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial

Conditions
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Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
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* Device: Automatic ventilation
* Device: Manual ventilation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic ventilation<br>After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds. | Device: Automatic ventilation<br>* 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 600 ml.<br>* Other names: automatic pneumatic ventilation (APV);|
| Active Comparator: Manual ventilation<br>After the advanced airway is placed, a bag valve mask resuscitator will be connected and provides ventilation in every 6 seconds by the emergency medical technician. | Device: Manual ventilation<br>* 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.<br>* Other names: Bag-valve-mask (BVM) ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of any return of spontaneous circulation (ROSC) | The patient achieved ROSC in prehospital or inhospital resuscitation. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of sustained ROSC in 24 hours | The patient survives for 24 hours after arriving the hospital. | up to 24 hours | 
| The percentage of survival to hospital discharge | The patient survives to discharge from the hospital. | up to 90 days | 
| The percentage of favorable neurological outcome after discharge | The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2. | up to 90 days | 
| Chest compression fraction | The chest compression fraction during prehospital resuscitation recorded by the monitor. | up to 1 hour | 
| The percentage of intravenous catheter placement | Whether the patient has an IV catheter placed in the prehospital setting. | up to 1 hour | 
| The percentage of epinephrine injection | Whether the patient has epinephrine injected in the prehospital setting. | up to 1 hour | 
| The satisfaction of emergency medical technician (EMT) during the dispatch | 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) | up to 5 hours | 
| The percentage of pneumothorax | Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy. | up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automatic ventilation, prehospital resuscitation, emergency medical service