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A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA

NCT ID: NCT02967952

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

852 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Prehospital Airway Management in Patients With Cardiac Arrest

Keywords

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out-of-hospital cardiac arrest (OHCA) supraglottic airway (SGA) endotracheal intubation (ETI) emergency medical system (EMS) Supraglottic Airway Versus Endotracheal tube (SAVE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

already being described above

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

already being described above

Interventions

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

already being described above

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Chu Chiang, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Emergency Dept, National Taiwan University Hospital

Central Contacts

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Wen-Chu Chiang, MD, PhD.

Role: CONTACT

Phone: +886-2-23123456

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 35179588 (View on PubMed)

Other Identifiers

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201606047RINA

Identifier Type: -

Identifier Source: org_study_id