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Automatic Ventilation in Prehospital Resuscitation on OHCA

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06067204
Collaborator
(none)
290
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Automatic ventilation
  • Device: Manual ventilation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Automatic ventilation

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

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 600 ml.
Other Names:
  • automatic pneumatic ventilation (APV)

    		•
    Active Comparator: 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.

    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.
    Other Names:
  • Bag-valve-mask (BVM) ventilation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The percentage of any return of spontaneous circulation (ROSC) [2 hours]

      The patient achieved ROSC in prehospital or inhospital resuscitation.

    Secondary Outcome Measures

    1. The percentage of sustained ROSC in 24 hours [up to 24 hours]

      The patient survives for 24 hours after arriving the hospital.

    2. The percentage of survival to hospital discharge [up to 90 days]

      The patient survives to discharge from the hospital.

    3. The percentage of favorable neurological outcome after discharge [up to 90 days]

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

    4. Chest compression fraction [up to 1 hour]

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

    5. The percentage of intravenous catheter placement [up to 1 hour]

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

    6. The percentage of epinephrine injection [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 [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 [up to 3 days]

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

    Other Outcome Measures

    1. Ventilation rate in the prehospital resuscitation [up to 1 hour]

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

    2. Tidal volume in the prehospital resuscitation [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 [up to 1 hour]

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

    4. Chest compression rate in the prehospital resuscitation [up to 1 hour]

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

    5. End-tidal carbon dioxide level (ETCO2) [1 hour]

      The ETCO2 recorded in the prehospital resuscitation process.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Hsinchu Branch Hsinchu Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Edward Pei-Chuan Huang, M.D., M.S., National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT06067204
    Other Study ID Numbers:
    • 202304132RINB
    First Posted:
    Oct 4, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by National Taiwan University Hospital
    automatic ventilation
    prehospital resuscitation
    emergency medical service
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest

    Study Results

    No Results Posted as of Oct 10, 2023