Prehospital Airway Management in Patients With Cardiac ArrestSAVENCT02967952
A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA
A study testing supraglottic airway (SGA) V.S. endotracheal intubation (ETI) in people with Prehospital Airway Management in Patients With Cardiac Arrest, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prehospital Airway Management in Patients With Cardiac Arrest
- What is being tested?
- supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- out-of-hospital cardiac arrest; OHCA
- age ≥ 20 years old
- non-traumatic cause
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
- Keywords
- out-of-hospital cardiac arrest (OHCA), supraglottic airway (SGA), endotracheal intubation (ETI), emergency medical system (EMS), Supraglottic Airway Versus Endotracheal tube (SAVE)
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic airway (SGA) V.S. endotracheal intubation (ETI)Device
already being described above
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival to admission
Measurement of outcome by standard Utstein OHCA registry system in Taipei City
Measured: One month after event
Secondary outcomes (3)
any ROSC
Measurement of outcome by standard Utstein OHCA registry system in Taipei City
Measured: One month after event
survival to discharge
Measurement of outcome by standard Utstein OHCA registry system in Taipei City
Measured: 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
Measured: One month after event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prehospital Airway Management in Patients With Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Chu Chiang, MD, PhD., Principal investigator, Emergency Dept, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967952
- Sponsor's protocol ID
- 201606047RINA
- Acronym
- SAVE
- Status last verified
- Nov 2016
- First submitted
- 20 Oct 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35179588
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)
- ClinicalTrials.gov ID
- NCT02967952
- Acronym / sponsor ID
- SAVE / 201606047RINA
- Keywords
- out-of-hospital cardiac arrest (OHCA), supraglottic airway (SGA), endotracheal intubation (ETI), emergency medical system (EMS), Supraglottic Airway Versus Endotracheal tube (SAVE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraglottic airway (SGA) | Active comparator | Device: supraglottic airway (SGA) V.S. 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 supraglottic airway (SGA). |
| endotracheal intubation (ETI) | Active comparator | Device: supraglottic airway (SGA) V.S. 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- out-of-hospital cardiac arrest; OHCA
- age ≥ 20 years old
- non-traumatic cause
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supraglottic airway (SGA) V.S. endotracheal intubation (ETI)already being described above | Device | endotracheal intubation (ETI), supraglottic airway (SGA) |
Primary outcome
survival to admission
Time frame: One month after event
Measurement of outcome by standard Utstein OHCA registry system in Taipei City
3 secondary outcomes
any ROSC
Time frame: One month after event
survival to discharge
Time frame: One month after event
favorable neurologic outcome
Time frame: One month after event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Derived from this study: PubMed 35179588Lee 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Chu Chiang, MD, PhD. principal investigator
Emergency Dept, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic airway (SGA) V.S. endotracheal intubation (ETI) in people with Prehospital Airway Management in Patients With Cardiac Arrest, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Chu Chiang, MD, PhD. (+886-2-23123456 ext. 62831, drchiang.tw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival to admission (time frame: One month after event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.