Automatic Ventilation in Prehospital Resuscitation on OHCA

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: Manual ventilation; Device: Automatic ventilation

• Study Type: Interventional
• Enrollment (Estimated): 514
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng Yi Fan, M.D.; Phone Number: +886972654382; Email: chengyi.md@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • Recruiting
    • National Taiwan University Hospital Hsinchu branch
    • Contact: Cheng-Yi Fan, M.D.; Phone Number: +886911438312; Email: chengyi.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 500-600 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of any return of spontaneous circulation (ROSC)	The patient achieved ROSC in prehospital or inhospital resuscitation.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of sustained ROSC in 24 hours	The patient survives for 24 hours after arriving the hospital.	up to 24 hours
The percentage of survival to hospital discharge	The patient survives to discharge from the hospital.	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.	up to 90 days
The percentage of intravenous catheter placement	Whether the patient has an IV catheter placed in the prehospital setting.	up to 1 hour
The percentage of epinephrine injection	Whether the patient has epinephrine injected in the prehospital setting.	up to 1 hour
The percentage of pneumothorax	Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.	up to 3 days
Chest compression fraction	The chest compression fraction during prehospital resuscitation recorded by the monitor.	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)	up to 5 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation rate in the prehospital resuscitation	The ventilation rate recorded by the portable monitor with feedback sensor (BVM help).	up to 1 hour
Tidal volume in the prehospital resuscitation	The tidal volume recorded by the portable monitor with feedback sensor (BVM help).	up to 1 hour
Chest compression depth in the prehospital resuscitation	The chest compression depth recorded by the portable monitor with feedback pad.	up to 1 hour
Chest compression rate in the prehospital resuscitation	The chest compression rate recorded by the portable monitor with feedback pad.	up to 1 hour
End-tidal carbon dioxide level (ETCO2)	The ETCO2 recorded in the prehospital resuscitation process.	1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: emergency medical service; automatic ventilation; prehospital resuscitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 202304132RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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