NCT02967952

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
852

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

October 20, 2016

Last Update Submit

November 15, 2016

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)

Outcome Measures

Primary Outcomes (1)

  • survival to admission

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

    One month after event

Secondary Outcomes (3)

  • any ROSC

    One month after event

  • survival to discharge

    One month after event

  • favorable neurologic outcome

    One month after event

Other Outcomes (4)

  • The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)

    One month after event

  • The interaction between age and airway management

    One month after event

  • The interaction between bystander CPR and airway management

    One month after event

  • +1 more other outcomes

Study Arms (2)

supraglottic airway (SGA)

ACTIVE COMPARATOR

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)

endotracheal intubation (ETI)

ACTIVE COMPARATOR

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)

Interventions

supraglottic airway (SGA) V.S. endotracheal intubation (ETI)DEVICE

already being described above

endotracheal intubation (ETI)supraglottic airway (SGA)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • out-of-hospital cardiac arrest; OHCA
  • age ≥ 20 years old
  • non-traumatic cause

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35179588DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Wen-Chu Chiang, MD, PhD.

    Emergency Dept, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Chu Chiang, MD, PhD.

CONTACT

+886-2-23123456drchiang.tw@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

November 18, 2016

Record last verified: 2016-11