Out-Of-Hospital Cardiac ArrestNCT06067204
Automatic Ventilation in Prehospital Resuscitation on OHCA
A study testing Automatic ventilation and Manual ventilation in people with Out-Of-Hospital Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Automatic ventilation and Manual ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2023to 30 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (OHCA).
- Attended by the Hsinchu County Fire Department for emergency medical assistance.
Who cannot join
- Pregnant women.
- OHCA caused by trauma.
- Return of spontaneous circulation (ROSC) observed at the scene.
- Clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture).
- Refusal of medical transportation by family members.
- No placement of an advanced airway throughout the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial
The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are:
- How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
- What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Automatic ventilation, Manual ventilation
- Keywords
- automatic ventilation, prehospital resuscitation, emergency medical service
- 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.
Automatic ventilationDevice
Also called automatic pneumatic ventilation (APV)
The device used is "Meditech" MICROVENT RESUSCITATOR, which is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. It is powered by the airflow from the oxygen tank and provides ventilation in fixed interval. It has a pressure valve which will release the pressure once the airway pressure exceeds its threshold. In the current study, the threshold is set at 60 cmH2O. The tidal volume is set at 500-600 ml.
Manual ventilationDevice
Also called Bag-valve-mask (BVM) ventilation
The adult size bag-valve mask is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. The interval, pressure and volume of the ventilation is controlled by the emergency medical technicians.
| Study group | Role | What they receive |
|---|---|---|
| Automatic ventilation | Experimental | Patients treated by an EMS team during a 14-day period allocated to automatic ventilation (allocation by EMS team-period). After the advanced airway is placed, an automatic pneumatic ventilator is connected and delivers one breath every 6 seconds (10 breaths per minute). Receives: Device: Automatic ventilation |
| Manual ventilation | Active comparator | Patients treated by an EMS team during a 14-day period allocated to manual ventilation (allocation by EMS team-period). After the advanced airway is placed, a bag-valve resuscitator is connected and the emergency medical technician delivers one breath every 6 seconds (10 breaths per minute). Receives: Device: Manual ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of any return of spontaneous circulation (ROSC)
The patient achieved ROSC in prehospital or inhospital resuscitation.
Measured: 2 hours
Secondary outcomes (8)
The percentage of sustained ROSC in 24 hours
The patient survives for 24 hours after arriving the hospital.
Measured: up to 24 hours
The percentage of survival to hospital discharge
The patient survives to discharge from the hospital.
Measured: up to 90 days
The percentage of favorable neurological outcome after discharge
The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2.
Measured: up to 90 days
Chest compression fraction
The chest compression fraction during prehospital resuscitation recorded by the monitor.
Measured: up to 1 hour
The percentage of intravenous catheter placement
Whether the patient has an IV catheter placed in the prehospital setting.
Measured: up to 1 hour
The percentage of epinephrine injection
Whether the patient has epinephrine injected in the prehospital setting.
Measured: up to 1 hour
The satisfaction of emergency medical technician (EMT) during the dispatch
The outcome contained five questions:
- More convenient to use
- Shorter time required to complete ventilation (from advanced airway placement to the start of ventilation)
- Smoother patient transport process
- Ability to perform more emergency medical techniques
- Overall satisfaction with the execution of emergency medical tasks
The EMTs answer in the 5-level scale (highly disagree, disagree, neutral, agree, highly agree)
Measured: up to 5 hours
The percentage of pneumothorax
Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start2 Oct 2023
- Primary completion15 Aug 2025
- Study completion30 Nov 2025
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 Out-Of-Hospital 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
- Crossover
- Model description
- Cluster randomised crossover trial. The unit of randomisation is the EMS team-period: each of 13 advanced life support EMS teams of the Hsinchu County Fire Bureau was assigned, in consecutive 14-day periods starting at 08:00 on Mondays, to automated pneumatic ventilation (APV) or manual bag-valve-mask ventilation (BVM) according to a computer-generated blocked sequence (block size 6, 1:1 allocation). Teams therefore switched repeatedly between the two strategies, and teams joined the trial in a staggered manner. All eligible patients treated by a team during a period received the ventilation strategy allocated to that team-period.
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Pei-Chuan Huang, M.D., M.S., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067204
- Sponsor's protocol ID
- 202304132RINB
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan CY, Huang SS, Chen CH, Sung CW, Chang CH, Hung TH, Liu YC, Huang EP. Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial). Resusc Plus. 2024 Nov 16;20:100827. doi: 10.1016/j.resplu.2024.100827. eCollection 2024 Dec.
PubMed 39624188
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06067204
- Acronym / sponsor ID
- 202304132RINB
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- automatic ventilation, prehospital resuscitation, emergency medical service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 4 Oct 2023 (actual)
- 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.
The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are:
- How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
- What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised crossover trial. The unit of randomisation is the EMS team-period: each of 13 advanced life support EMS teams of the Hsinchu County Fire Bureau was assigned, in consecutive 14-day periods starting at 08:00 on Mondays, to automated pneumatic ventilation (APV) or manual bag-valve-mask ventilation (BVM) according to a computer-generated blocked sequence (block size 6, 1:1 allocation). Teams therefore switched repeatedly between the two strategies, and teams joined the trial in a staggered manner. All eligible patients treated by a team during a period received the ventilation strategy allocated to that team-period.
| Arm | Type | Receives |
|---|---|---|
| Automatic ventilation | Experimental | Device: Automatic ventilationPatients treated by an EMS team during a 14-day period allocated to automatic ventilation (allocation by EMS team-period). After the advanced airway is placed, an automatic pneumatic ventilator is connected and delivers one breath every 6 seconds (10 breaths per minute). |
| Manual ventilation | Active comparator | Device: Manual ventilationPatients treated by an EMS team during a 14-day period allocated to manual ventilation (allocation by EMS team-period). After the advanced airway is placed, a bag-valve resuscitator is connected and the emergency medical technician delivers one breath every 6 seconds (10 breaths per minute). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (OHCA).
- Attended by the Hsinchu County Fire Department for emergency medical assistance.
Key exclusion criteria (6 listed)
- Pregnant women.
- OHCA caused by trauma.
- Return of spontaneous circulation (ROSC) observed at the scene.
- Clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture).
- Refusal of medical transportation by family members.
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 |
|---|---|---|
| Automatic ventilationAlso: automatic pneumatic ventilation (APV)The device used is "Meditech" MICROVENT RESUSCITATOR, which is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. It is powered by the airflow from the oxygen tank and provides ventilation in fixed interval. It has a pressure valve which will release the pressure once the airway pressure exceeds its threshold. In the current study, the threshold is set at 60 cmH2O. The tidal volume is set at 500-600 ml. | Device | Automatic ventilation |
| Manual ventilationAlso: Bag-valve-mask (BVM) ventilationThe adult size bag-valve mask is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. The interval, pressure and volume of the ventilation is controlled by the emergency medical technicians. | Device | Manual ventilation |
Primary outcome
The percentage of any return of spontaneous circulation (ROSC)
Time frame: 2 hours
The patient achieved ROSC in prehospital or inhospital resuscitation.
8 secondary outcomes
The percentage of sustained ROSC in 24 hours
Time frame: up to 24 hours
The percentage of survival to hospital discharge
Time frame: up to 90 days
The percentage of favorable neurological outcome after discharge
Time frame: up to 90 days
Chest compression fraction
Time frame: up to 1 hour
The percentage of intravenous catheter placement
Time frame: up to 1 hour
The percentage of epinephrine injection
Time frame: up to 1 hour
The satisfaction of emergency medical technician (EMT) during the dispatch
Time frame: up to 5 hours
The percentage of pneumothorax
Time frame: up to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 39624188Fan CY, Huang SS, Chen CH, Sung CW, Chang CH, Hung TH, Liu YC, Huang EP. Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial). Resusc Plus. 2024 Nov 16;20:100827. doi: 10.1016/j.resplu.2024.100827. eCollection 2024 Dec.
- Individual participant dataSharing planned: No
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
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The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
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Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
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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.
Edward Pei-Chuan Huang, M.D., M.S. study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic ventilation and Manual ventilation in people with Out-Of-Hospital Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of any return of spontaneous circulation (ROSC) (time frame: 2 hours). 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 NCT06067204, 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 20 Oct 2026.