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

National Taiwan University

Status: Unknown

Conditions: Prehospital Airway Management in Patients With Cardiac Arrest

Treatments: Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02967952

201606047RINA

Details and patient eligibility

About

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.

Enrollment: 852 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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852 participants in 2 patient groups

supraglottic airway (SGA)

Active Comparator group

Description:

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).

Treatment:

Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)

endotracheal intubation (ETI)

Active Comparator group

Description:

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).

Treatment:

Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)