Clinical trial NCT02967952: A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA
Official title: A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prehospital Airway Management in Patients With Cardiac Arrest
Keywords: out-of-hospital cardiac arrest (OHCA)
supraglottic airway (SGA)
endotracheal intubation (ETI)
emergency medical system (EMS)
Supraglottic Airway Versus Endotracheal tube (SAVE)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 852
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: survival to admission
timeFrame: One month after event
Secondary outcomes:
measure: any ROSC
timeFrame: One month after event
measure: survival to discharge
timeFrame: One month after event
measure: favorable neurologic outcome
timeFrame: One month after event
Other outcomes:
measure: The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)
timeFrame: One month after event
measure: The interaction between age and airway management
timeFrame: One month after event
measure: The interaction between bystander CPR and airway management
timeFrame: One month after event
measure: The interaction between shockable rhythms and airway management
timeFrame: One month after event
Locations:
Study officials:
affiliation: Emergency Dept, National Taiwan University Hospital
name: Wen-Chu Chiang, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee AF, Chien YC, Lee BC, Yang WS, Wang YC, Lin HY, Huang EP, Chong KM, Sun JT, Huei-Ming M, Hsieh MJ, Chiang WC. Effect of Placement of a Supraglottic Airway Device vs Endotracheal Intubation on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest in Taipei, Taiwan: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148871. doi: 10.1001/jamanetworkopen.2021.48871.