Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial).
Cheng-Yi Fan, Sih-Shiang Huang, Chi-Hsin Chen...
https://pubmed.ncbi.nlm.nih.gov/39624188Actively Recruiting
Led by National Taiwan University Hospital · Updated on 2024-11-27
514
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research aims to compare two ventilation strategies used before hospital arrival in patients who experience out-of-hospital cardiac arrest (OHCA). The study evaluates how automatic ventilation compares to manual ventilation in terms of patient survival, neurological outcomes, and quality of resuscitation. Researchers want to understand whether automatic ventilation affects the chance of return of spontaneous circulation (ROSC) and overall prognosis compared to manual ventilation provided by emergency medical technicians. Participants will be randomly assigned to one of two groups after placement of an advanced airway. In the automatic ventilation group, a pneumatic ventilator device called Meditech MICROVENT RESUSCITATOR is connected to provide breaths every 6 seconds with set pressure and volume. In the manual ventilation group, emergency medical technicians use a bag valve mask to provide breaths every 6 seconds manually. The device settings and ventilation intervals are controlled differently between the groups to compare the two methods. During the study, researchers will monitor outcomes such as the percentage of patients achieving ROSC within 2 hours, sustained ROSC at 24 hours, survival to hospital discharge up to 90 days, and neurological status after discharge. They will also measure chest compression fraction, intravenous catheter placement, epinephrine use, technician satisfaction during dispatch, and incidence of pneumothorax. The study duration and follow-up extend up to 90 days after hospital discharge to assess longer-term outcomes.
CONDITIONS
Automatic Ventilation in Prehospital Resuscitation on OHCA
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 1 hour during prehospital resuscitation
Participants receive either automatic ventilation using a pneumatic ventilator connected to their airway or manual ventilation using a bag valve mask by emergency medical technicians during resuscitation.
1 treatment period during emergency care
Duration - Up to 90 days after resuscitation
Participants are monitored for return of spontaneous circulation, survival, neurological outcomes, and safety events after treatment.
Assessments at 2 hours, 24 hours, up to 3 days, and up to 90 days post-treatment
Total: 1 location
1
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Actively Recruiting
C
Cheng Yi Fan, M.D.
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Cheng-Yi Fan, Sih-Shiang Huang, Chi-Hsin Chen...
https://pubmed.ncbi.nlm.nih.gov/39624188