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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prehospital Airway Management in Patients With Cardiac Arrest
• Intervention / Treatment: Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)

• Study Type: Interventional
• Enrollment (Anticipated): 852
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: supraglottic airway (SGA); 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); already being described above
Active Comparator: 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).	Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI); already being described above

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)	Measurement of outcome by standard Utstein OHCA registry system in Taipei City	One month after event
The interaction between age and airway management	Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City	One month after event
The interaction between bystander CPR and airway management	Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City	One month after event
The interaction between shockable rhythms and airway management	Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City	One month after event

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wen-Chu Chiang, MD, PhD., Emergency Dept, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: out-of-hospital cardiac arrest (OHCA); supraglottic airway (SGA); endotracheal intubation (ETI); emergency medical system (EMS); Supraglottic Airway Versus Endotracheal tube (SAVE)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 201606047RINA