Automatic Ventilation in Prehospital Resuscitation on OHCA

NCT ID: NCT06067204

Last Updated: 2024-11-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2026-09-30

Brief Summary

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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. How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
2. What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.

Detailed Description

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Conditions

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Out-Of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Only the emergency medical service crew will know the intervention in each participant. The patient will not be aware of the type of ventilation strategy because of OHCA status. The investigator and outcomes assessor will not able to acquire the allocation results until the study ends.

Study Groups

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Automatic ventilation

After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds.

Group Type EXPERIMENTAL

Automatic ventilation

Intervention Type DEVICE

The FDA-approved 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 mmH2O. The tidal volume is set at 500-600 ml.

Manual ventilation

After the advanced airway is placed, a bag valve mask resuscitator will be connected and provides ventilation in every 6 seconds by the emergency medical technician.

Group Type ACTIVE_COMPARATOR

Manual ventilation

Intervention Type DEVICE

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.

Interventions

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Automatic ventilation

The FDA-approved 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 mmH2O. The tidal volume is set at 500-600 ml.

Intervention Type DEVICE

Manual 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.

Intervention Type DEVICE

Other Intervention Names

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automatic pneumatic ventilation (APV) Bag-valve-mask (BVM) ventilation

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 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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Edward Pei-Chuan Huang, M.D., M.S.

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital Hsinchu Branch

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng Yi Fan, M.D.

Role: CONTACT

+886972654382

Facility Contacts

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Cheng-Yi Fan, M.D.

Role: primary

+886911438312

References

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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.

Reference Type DERIVED
PMID: 39624188 (View on PubMed)

Other Identifiers

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202304132RINB

Identifier Type: -

Identifier Source: org_study_id