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NCT Number: NCT06067204

Automatic Ventilation in Prehospital Resuscitation on OHCA

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

Location status: Recruiting

Location contact

Cheng-Yi Fan, M.D.

CONTACT

[email protected]

+886911438312

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automatic ventilation

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.

Other names: automatic pneumatic ventilation (APV)

Manual Ventilation

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.

Other names: Bag-valve-mask (BVM) ventilation

Primary outcomes

  1. The percentage of any return of spontaneous circulation (ROSC)

    Time frame: 2 hours

    The patient achieved ROSC in prehospital or inhospital resuscitation.

Secondary outcomes

  1. The percentage of sustained ROSC in 24 hours

    Time frame: up to 24 hours

    The patient survives for 24 hours after arriving the hospital.

  2. The percentage of survival to hospital discharge

    Time frame: up to 90 days

    The patient survives to discharge from the hospital.

  3. The percentage of favorable neurological outcome after discharge

    Time frame: up to 90 days

    The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2.

  4. Chest compression fraction

    Time frame: up to 1 hour

    The chest compression fraction during prehospital resuscitation recorded by the monitor.

  5. The percentage of intravenous catheter placement

    Time frame: up to 1 hour

    Whether the patient has an IV catheter placed in the prehospital setting.

  6. The percentage of epinephrine injection

    Time frame: up to 1 hour

    Whether the patient has epinephrine injected in the prehospital setting.

  7. The satisfaction of emergency medical technician (EMT) during the dispatch

    Time frame: up to 5 hours

    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)

  8. The percentage of pneumothorax

    Time frame: up to 3 days

    Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.

Other outcomes

  1. Ventilation rate in the prehospital resuscitation

    Time frame: up to 1 hour

    The ventilation rate recorded by the portable monitor with feedback sensor (BVM help).

  2. Tidal volume in the prehospital resuscitation

    Time frame: up to 1 hour

    The tidal volume recorded by the portable monitor with feedback sensor (BVM help).

  3. Chest compression depth in the prehospital resuscitation

    Time frame: up to 1 hour

    The chest compression depth recorded by the portable monitor with feedback pad.

  4. Chest compression rate in the prehospital resuscitation

    Time frame: up to 1 hour

    The chest compression rate recorded by the portable monitor with feedback pad.

  5. End-tidal carbon dioxide level (ETCO2)

    Time frame: 1 hour

    The ETCO2 recorded in the prehospital resuscitation process.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Yi Fan, M.D.

CONTACT

[email protected]

+886972654382

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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