Clinical trial NCT06067204: Automatic Ventilation in Prehospital Resuscitation on OHCA
Official title: Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: automatic ventilation
prehospital resuscitation
emergency medical service
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The percentage of any return of spontaneous circulation (ROSC)
timeFrame: 2 hours
Secondary outcomes:
measure: The percentage of sustained ROSC in 24 hours
timeFrame: up to 24 hours
measure: The percentage of survival to hospital discharge
timeFrame: up to 90 days
measure: The percentage of favorable neurological outcome after discharge
timeFrame: up to 90 days
measure: Chest compression fraction
timeFrame: up to 1 hour
measure: The percentage of intravenous catheter placement
timeFrame: up to 1 hour
measure: The percentage of epinephrine injection
timeFrame: up to 1 hour
measure: The satisfaction of emergency medical technician (EMT) during the dispatch
timeFrame: up to 5 hours
measure: The percentage of pneumothorax
timeFrame: up to 3 days
Other outcomes:
measure: Ventilation rate in the prehospital resuscitation
timeFrame: up to 1 hour
measure: Tidal volume in the prehospital resuscitation
timeFrame: up to 1 hour
measure: Chest compression depth in the prehospital resuscitation
timeFrame: up to 1 hour
measure: Chest compression rate in the prehospital resuscitation
timeFrame: up to 1 hour
measure: End-tidal carbon dioxide level (ETCO2)
timeFrame: 1 hour
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Edward Pei-Chuan Huang, M.D., M.S.
role: STUDY_CHAIR
References: