Automatic Ventilation in Prehospital Resuscitation on OHCA

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067204
• Other study ID #: 202304132RINB
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: September 2023
• Source: National Taiwan University Hospital
• Contact: Cheng Yi Fan, M.D.
• Phone: +886972654382
• Email: chengyi.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: September 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsinchu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ventilation rate in the prehospital resuscitation	The ventilation rate recorded by the portable monitor with feedback sensor (BVM help).	up to 1 hour
Other	Tidal volume in the prehospital resuscitation	The tidal volume recorded by the portable monitor with feedback sensor (BVM help).	up to 1 hour
Other	Chest compression depth in the prehospital resuscitation	The chest compression depth recorded by the portable monitor with feedback pad.	up to 1 hour
Other	Chest compression rate in the prehospital resuscitation	The chest compression rate recorded by the portable monitor with feedback pad.	up to 1 hour
Other	End-tidal carbon dioxide level (ETCO2)	The ETCO2 recorded in the prehospital resuscitation process.	1 hour
Primary	The percentage of any return of spontaneous circulation (ROSC)	The patient achieved ROSC in prehospital or inhospital resuscitation.	2 hours
Secondary	The percentage of sustained ROSC in 24 hours	The patient survives for 24 hours after arriving the hospital.	up to 24 hours
Secondary	The percentage of survival to hospital discharge	The patient survives to discharge from the hospital.	up to 90 days
Secondary	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
Secondary	Chest compression fraction	The chest compression fraction during prehospital resuscitation recorded by the monitor.	up to 1 hour
Secondary	The percentage of intravenous catheter placement	Whether the patient has an IV catheter placed in the prehospital setting.	up to 1 hour
Secondary	The percentage of epinephrine injection	Whether the patient has epinephrine injected in the prehospital setting.	up to 1 hour
Secondary	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
Secondary	The percentage of pneumothorax	Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.	up to 3 days