Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06067204

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

Led by National Taiwan University Hospital · Updated on 2024-11-27

514

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Automatic Ventilation in Prehospital Resuscitation on OHCA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Pregnant women.
  • OHCA caused by trauma.
  • Return of spontaneous circulation (ROSC) observed at the scene.
  • Clearly deceased at the scene (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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

Actively Recruiting

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Research Team

C

Cheng Yi Fan, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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/39624188