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A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02967952
Acronym
SAVE
Enrollment
852
Registered
2016-11-18
Start date
2016-11-30
Completion date
2019-12-31
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

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

already being described above

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
survival to admissionOne month after eventMeasurement of outcome by standard Utstein OHCA registry system in Taipei City

Secondary

MeasureTime frameDescription
any ROSCOne month after eventMeasurement of outcome by standard Utstein OHCA registry system in Taipei City
survival to dischargeOne month after eventMeasurement of outcome by standard Utstein OHCA registry system in Taipei City
favorable neurologic outcomeOne month after eventFavorable neurologic outcome was defined by CPC (cerebral performance category) 1 and 2. Measurement of outcome by standard Utstein OHCA registry system in Taipei City

Other

MeasureTime frameDescription
The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)One month after eventMeasurement of outcome by standard Utstein OHCA registry system in Taipei City
The interaction between age and airway managementOne month after eventDeciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
The interaction between bystander CPR and airway managementOne month after eventDeciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
The interaction between shockable rhythms and airway managementOne month after eventDeciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City

Contacts

Primary ContactWen-Chu Chiang, MD, PhD.
drchiang.tw@gmail.com+886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026