search
Back to results

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

Primary Purpose

Prehospital Airway Management in Patients With Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehospital Airway Management in Patients With Cardiac Arrest focused on measuring out-of-hospital cardiac arrest (OHCA), supraglottic airway (SGA), endotracheal intubation (ETI), emergency medical system (EMS), Supraglottic Airway Versus Endotracheal tube (SAVE)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    supraglottic airway (SGA)

    endotracheal intubation (ETI)

    Arm 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).

    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).

    Outcomes

    Primary Outcome Measures

    survival to admission
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City

    Secondary Outcome Measures

    any ROSC
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    survival to discharge
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    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

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    November 15, 2016
    Sponsor
    National Taiwan University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02967952
    Brief Title
    A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA
    Acronym
    SAVE
    Official Title
    A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    852 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    supraglottic airway (SGA)
    Arm Type
    Active Comparator
    Arm 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).
    Arm Title
    endotracheal intubation (ETI)
    Arm Type
    Active Comparator
    Arm 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).
    Intervention Type
    Device
    Intervention Name(s)
    supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
    Intervention Description
    already being described above
    Primary Outcome Measure Information:
    Title
    survival to admission
    Description
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Secondary Outcome Measure Information:
    Title
    any ROSC
    Description
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Title
    survival to discharge
    Description
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Title
    favorable neurologic outcome
    Description
    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
    Time Frame
    One month after event
    Other Pre-specified Outcome Measures:
    Title
    The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)
    Description
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Title
    The interaction between age and airway management
    Description
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Title
    The interaction between bystander CPR and airway management
    Description
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event
    Title
    The interaction between shockable rhythms and airway management
    Description
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
    Time Frame
    One month after event

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wen-Chu Chiang, MD, PhD.
    Phone
    +886-2-23123456
    Ext
    62831
    Email
    drchiang.tw@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Chu Chiang, MD, PhD.
    Organizational Affiliation
    Emergency Dept, National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35179588
    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.
    Results Reference
    derived

    Learn more about this trial

    A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA

    We'll reach out to this number within 24 hrs