Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial).

Aims: The PIVOT trial evaluates the clinical outcomes and ventilatory quality of an automatic pneumatic ventilation method compared to a bag-valve-mask ventilation method in patients who have experienced out-of-hospital cardiac arrest and have had an advanced airway placed. Methods: The PIVOT trial is a pragmatic, open-label, multicenter randomized controlled trial. It aims to recruit 514 patients in Hsinchu County, Taiwan. Adult, non-trauma patients who experience out-of-hospital cardiac arrest, are treated by emergency medical services, and have an advanced airway in place will be randomized. Biweekly cluster randomization will assign EMS teams to either the automatic pneumatic ventilation group or the bag-valve-mask group. Informed consent is waived. The primary outcome is the return of spontaneous circulation, either prehospital or in-hospital. Secondary outcomes include survival to discharge, neurological outcomes, prehospital ventilatory quality, and the content of prehospital resuscitation. Participants will be followed until they pass away or are discharged from the hospital. Conclusion: The PIVOT trial will provide new insight on the clinical effectiveness of automatic pneumatic ventilation in patients experienced out-of-hospital cardiac arrest. Trial number: NCT06067204 in clinicaltrial.gov