A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA

Study Overview
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Brief Summary
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In this 3-year successive research plan, investigators will conduct a prehospital randomized controlled trial to address the following question: In adult patients with non-traumatic cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation cause a better chance of sustained recovery of spontaneous circulation and other survival outcomes like neurologically favorable status, comparing to those who receiving supraglottic airway device.

Official Title
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A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)

Conditions
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Prehospital Airway Management in Patients With Cardiac Arrest

Intervention / Treatment
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* Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: out-of-hospital cardiac arrest; OHCA age ≥ 20 years old non-traumatic cause Exclusion Criteria: signs of obvious death, eg. decapitation or rigor mortis theoretically not suitable for ETI, eg. facial deformity or third-trimester pregnancy theoretically not suitable for SGA, eg. foreign-body airway obstruction with do not attempt resuscitation order the occurrence of OHCA during ambulance transport ROSC in the field with clear consciousness and spontaneous adequate ventilation advanced airway being established before the arrival of paramedics

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supraglottic airway (SGA)<br>Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of supraglottic airway (SGA). | Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)<br>* already being described above<br>|
| Active Comparator: endotracheal intubation (ETI)<br>Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of endotracheal intubation (ETI). | Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)<br>* already being described above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival to admission | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any ROSC | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | 
| survival to discharge | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | 
| favorable neurologic outcome | Favorable neurologic outcome was defined by CPC (cerebral performance category) 1 and 2. Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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out-of-hospital cardiac arrest (OHCA), supraglottic airway (SGA), endotracheal intubation (ETI), emergency medical system (EMS), Supraglottic Airway Versus Endotracheal tube (SAVE)