A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA

Not Applicable

• Conditions: Prehospital Airway Management in Patients With Cardiac Arrest
• Interventions: Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)

• Registration Number: NCT02967952
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-15
• Last Update Submitted: 2016-11-15
• Study First Posted: 2016-11-18
• Last Update Posted: 2016-11-18
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 852

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supraglottic airway (SGA)	supraglottic airway (SGA) V.S. endotracheal intubation (ETI)	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).
endotracheal intubation (ETI)	supraglottic airway (SGA) V.S. endotracheal intubation (ETI)	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).

Primary Outcome Measures

Name	Time	Method
survival to admission	One month after event	Measurement of outcome by standard Utstein OHCA registry system in Taipei City

Secondary Outcome Measures

Name	Time	Method
survival to discharge	One month after event	Measurement of outcome by standard Utstein OHCA registry system in Taipei City
favorable neurologic outcome	One month after event	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
any ROSC	One month after event	Measurement of outcome by standard Utstein OHCA registry system in Taipei City