Menu
Recruiting NCT06067204

Automatic Ventilation in Prehospital Resuscitation on OHCA

No phase Interventional Out-Of-Hospital Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Automatic ventilation, Manual ventilation.
Who it may be relevant to
Registry conditions: Out-Of-Hospital Cardiac Arrest. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial

Overview

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.

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • The percentage of any return of spontaneous circulation (ROSC) [Time frame: 2 hours]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsinchu Branch — Hsinchu

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. PMID 39624188

Identifiers

NCT: NCT06067204 · 202304132RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗