Back to resultsAutomatic Ventilation in Prehospital Resuscitation on OHCA
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Automatic ventilation
Manual ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring automatic ventilation, prehospital resuscitation, emergency medical service
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.
Sites / Locations
- National Taiwan University Hospital Hsinchu BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Automatic ventilation
Manual ventilation
Arm Description
After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds.
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.
Outcomes
Primary Outcome Measures
The percentage of any return of spontaneous circulation (ROSC)
The patient achieved ROSC in prehospital or inhospital resuscitation.
Secondary Outcome Measures
The percentage of sustained ROSC in 24 hours
The patient survives for 24 hours after arriving the hospital.
The percentage of survival to hospital discharge
The patient survives to discharge from the hospital.
The percentage of favorable neurological outcome after discharge
The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2.
Chest compression fraction
The chest compression fraction during prehospital resuscitation recorded by the monitor.
The percentage of intravenous catheter placement
Whether the patient has an IV catheter placed in the prehospital setting.
The percentage of epinephrine injection
Whether the patient has epinephrine injected in the prehospital setting.
The satisfaction of emergency medical technician (EMT) during the dispatch
The outcome contained five questions:
More convenient to use
Shorter time required to complete ventilation (from advanced airway placement to the start of ventilation)
Smoother patient transport process
Ability to perform more emergency medical techniques
Overall satisfaction with the execution of emergency medical tasks
The EMTs answer in the 5-level scale (highly disagree, disagree, neutral, agree, highly agree)
The percentage of pneumothorax
Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.
Full Information
NCT ID
NCT06067204
First Posted
September 27, 2023
Last Updated
October 6, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06067204
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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:
How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
automatic ventilation, prehospital resuscitation, emergency medical service
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
290 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automatic ventilation
Arm Type
Experimental
Arm Description
After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds.
Arm Title
Manual ventilation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automatic ventilation
Other Intervention Name(s)
automatic pneumatic ventilation (APV)
Intervention Description
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 600 ml.
Intervention Type
Device
Intervention Name(s)
Manual ventilation
Other Intervention Name(s)
Bag-valve-mask (BVM) ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of any return of spontaneous circulation (ROSC)
Description
The patient achieved ROSC in prehospital or inhospital resuscitation.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
The percentage of sustained ROSC in 24 hours
Description
The patient survives for 24 hours after arriving the hospital.
Time Frame
up to 24 hours
Title
The percentage of survival to hospital discharge
Description
The patient survives to discharge from the hospital.
Time Frame
up to 90 days
Title
The percentage of favorable neurological outcome after discharge
Description
The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2.
Time Frame
up to 90 days
Title
Chest compression fraction
Description
The chest compression fraction during prehospital resuscitation recorded by the monitor.
Time Frame
up to 1 hour
Title
The percentage of intravenous catheter placement
Description
Whether the patient has an IV catheter placed in the prehospital setting.
Time Frame
up to 1 hour
Title
The percentage of epinephrine injection
Description
Whether the patient has epinephrine injected in the prehospital setting.
Time Frame
up to 1 hour
Title
The satisfaction of emergency medical technician (EMT) during the dispatch
Description
The outcome contained five questions:
More convenient to use
Shorter time required to complete ventilation (from advanced airway placement to the start of ventilation)
Smoother patient transport process
Ability to perform more emergency medical techniques
Overall satisfaction with the execution of emergency medical tasks
The EMTs answer in the 5-level scale (highly disagree, disagree, neutral, agree, highly agree)
Time Frame
up to 5 hours
Title
The percentage of pneumothorax
Description
Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy.
Time Frame
up to 3 days
Other Pre-specified Outcome Measures:
Title
Ventilation rate in the prehospital resuscitation
Description
The ventilation rate recorded by the portable monitor with feedback sensor (BVM help).
Time Frame
up to 1 hour
Title
Tidal volume in the prehospital resuscitation
Description
The tidal volume recorded by the portable monitor with feedback sensor (BVM help).
Time Frame
up to 1 hour
Title
Chest compression depth in the prehospital resuscitation
Description
The chest compression depth recorded by the portable monitor with feedback pad.
Time Frame
up to 1 hour
Title
Chest compression rate in the prehospital resuscitation
Description
The chest compression rate recorded by the portable monitor with feedback pad.
Time Frame
up to 1 hour
Title
End-tidal carbon dioxide level (ETCO2)
Description
The ETCO2 recorded in the prehospital resuscitation process.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Yi Fan, M.D.
Phone
+886972654382
Email
chengyi.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Pei-Chuan Huang, M.D., M.S.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital Hsinchu Branch
City
Hsinchu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Yi Fan, M.D.
Phone
+886911438312
Email
chengyi.md@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Automatic Ventilation in Prehospital Resuscitation on OHCA
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