Automatic Ventilation in Prehospital Resuscitation on OHCA

NCT06067204 | Recruiting DMC FDA Device

• 1 other identifier: 202304132RINB
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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. 1.How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
2. 2.What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

automatic ventilation; prehospital resuscitation; emergency medical service

Outcome Measures

Primary Outcomes (1)

• The percentage of any return of spontaneous circulation (ROSC)

  The patient achieved ROSC in prehospital or inhospital resuscitation.

  2 hours

Secondary Outcomes (8)

• The percentage of sustained ROSC in 24 hours

  up to 24 hours

• The percentage of survival to hospital discharge

  up to 90 days

• The percentage of favorable neurological outcome after discharge

  up to 90 days

• Chest compression fraction

  up to 1 hour

• The percentage of intravenous catheter placement

  up to 1 hour

Other Outcomes (5)

• Ventilation rate in the prehospital resuscitation

  up to 1 hour

• Tidal volume in the prehospital resuscitation

  up to 1 hour

• Chest compression depth in the prehospital resuscitation

  up to 1 hour

Study Arms (2)

Automatic ventilation

EXPERIMENTAL

After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds.

Device: Automatic ventilation

Manual ventilation

ACTIVE COMPARATOR

After the advanced airway is placed, a bag valve mask resuscitator will be connected and provides ventilation in every 6 seconds by the emergency medical technician.

Device: Manual ventilation

Interventions

Automatic ventilation DEVICE

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 500-600 ml.

Also known as: automatic pneumatic ventilation (APV)

Automatic ventilation

Manual ventilation DEVICE

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.

Also known as: Bag-valve-mask (BVM) ventilation

Manual ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (1)

• Fan CY, Huang SS, Chen CH, Sung CW, Chang CH, Hung TH, Liu YC, Huang EP. Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial). Resusc Plus. 2024 Nov 16;20:100827. doi: 10.1016/j.resplu.2024.100827. eCollection 2024 Dec.

  PMID: 39624188 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Edward Pei-Chuan Huang, M.D., M.S.

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Cheng Yi Fan, M.D.

CONTACT

+886972654382; chengyi.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the emergency medical service crew will know the intervention in each participant. The patient will not be aware of the type of ventilation strategy because of OHCA status. The investigator and outcomes assessor will not able to acquire the allocation results until the study ends.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: October 2, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)