Ventilation Monitoring in OHCA
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Zoll Accuvent Ventilation Monitor
Sponsored by
About this trial
This is an interventional other trial for Out-Of-Hospital Cardiac Arrest focused on measuring Ventilation, Cardiac Arrest, Resuscitation
Eligibility Criteria
Inclusion Criteria:
- All adult out-of-hospital cardiac arrests treated by paramedics
Exclusion Criteria:
- traumatic cardiac arrest
- prehospital Do Not Resuscitate (DNR) orders
Sites / Locations
- Sunnybrook Health Science CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Before Arm
After Arm
Arm Description
The before arm of the study prehospital providers will provide resuscitation as per standard practice. The providers will utilize the Zoll Accuvent device without activation of the real-time dashboard. This will allow us to collect baseline ventilation data.
The after arm of the study the prehospital providers will provide resuscitation as per standard practice. The real-time ventilation dashboard will be activated and the providers will use real-time feedback to monitor ventilation quality during the resuscitation.
Outcomes
Primary Outcome Measures
Ventilation Volume
Measurement of the volume of ventilation (mL) during resuscitation
Secondary Outcome Measures
Feasibility of successfully using Zoll Accuvent device in the field Feasibility
Ability to use the Zoll Accuvent during the resuscitation, obtain feedback, and download ventilation information. Feasibility will be defined as >80% success rate.
Prehospital Return of spontaneous circulation (ROSC)
any return of circulation in the prehospital setting as documented by paramedics
Ventilation Rate
Measure the rate (per minute) of ventilations delivered during resuscitation
Full Information
NCT ID
NCT04988906
First Posted
July 16, 2021
Last Updated
January 11, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Prescott-Russell Paramedic Service, Peterborough Paramedic Service, Bruce County Paramedic Service, Waterloo Paramedic Service
1. Study Identification
Unique Protocol Identification Number
NCT04988906
Brief Title
Ventilation Monitoring in OHCA
Official Title
Monitoring Ventilations During Out-of-Hospital Cardiac Arrest Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Prescott-Russell Paramedic Service, Peterborough Paramedic Service, Bruce County Paramedic Service, Waterloo Paramedic Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a before-and-after study examining the impact of real-time ventilation monitoring during out-of-hospital cardiac arrest. Study investigators will compare ventilation quality (rate, volume) performed during the resuscitation without the real-time feedback (before phase), to ventilation quality with the use of real-time feedback using the Zoll Accuvent device (after phase).
Detailed Description
The before intervention phase of this study will involve no change in practice to cardiac resuscitation by paramedics. Paramedics will be instructed to attach the Zoll AccuVent® to the BVM at each use and to leave it attached throughout the duration of the resuscitation.
During the resuscitation the Zoll AccuVent® will monitor and record ventilation rates and volumes that are being delivered during each ventilation performed utilizing the "Real BVM Help®" dashboard, however rescuers will be blinded to this information and will not be able to access it during the resuscitation. Post-call paramedics will upload the Zoll file containing the ventilation data in addition to CPR quality data and cardiac rhythms. This is consistent with current standard practice. These files will then be used by study investigators for data analysis. During this initial phase, to avoid biasing the study results the paramedics will only be trained on application of the Zoll AccuVent®, but will not have access to the real-time dashboard.
The study intervention will involve a brief training session for paramedics during the annual continuing medical education (CME) day. Training will consist of specifics of the study as well as how to apply the Zoll AccuVent® device and use the device during a cardiac arrest. Paramedics will be reminded of good ventilation practices during cardiac arrest and post-cardiac arrest care as well as current standards of practice as defined by the American Heart Association and Heart and Stroke Foundation of Canada.
Post-intervention, paramedics will be "un-blinded" and able to utilize the real-time feedback from the Zoll AccuVent® to help guide the delivery of ventilations during cardiac arrest resuscitation. All other aspects of care will be provided in accordance with standard practice at that time. Once the Zoll AccuVent® is applied, paramedics will use the real-time monitoring capabilities of the device to monitor the delivery of ventilations (rate and volume) during the resuscitation. Post-call paramedics will again upload files containing ventilation data that study investigators will analyze to compare our results.
Bivariate descriptive statistics will be used to examine differences in ventilation parameters between paramedics while using the Zoll AccuVent® and using standard monitoring devices (standard of care). The mean volume (mL) will be calculated for each of the two groups and Student's t-test will be used to compare the mean difference in volume (mL) between groups. Investigators will compare the proportion of ventilations per minute that are compliant with AHA guideline recommendations using Chi-square test for proportions.
The relationship between ventilations (volume and rate) and ROSC will be assessed using Poisson regression with robust standard errors. The results will be reported as relative risks (RR) and 95% confidence intervals for each of the included variables.
The volume of ventilations (mL) will be evaluated as a continuous variable, with secondary analyses analyzing per increase of 10mL as well as by quintiles of ventilation volume provided. The rate of ventilations will be analyzed categorically as "Compliant (8-10 per minute)", "Too Slow (< 8 per minute)", or "Too Fast (> 10 per minute)". Regression models will control for standard Utstein variables and additional modelling will examine for interactions between ventilation parameters and patient sex, patient age, initial rhythm and witness status. If a significant interaction is found subgroup analyses will be performed examining these specific groups.
A priori subgroup analyses will be performed examining differences between airway strategies (BVM vs. endotracheal intubation vs. supraglottic airway) as well as intra-arrest and post-arrest management.
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
Ventilation, Cardiac Arrest, Resuscitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before-and-After Design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Before Arm
Arm Type
No Intervention
Arm Description
The before arm of the study prehospital providers will provide resuscitation as per standard practice. The providers will utilize the Zoll Accuvent device without activation of the real-time dashboard. This will allow us to collect baseline ventilation data.
Arm Title
After Arm
Arm Type
Active Comparator
Arm Description
The after arm of the study the prehospital providers will provide resuscitation as per standard practice. The real-time ventilation dashboard will be activated and the providers will use real-time feedback to monitor ventilation quality during the resuscitation.
Intervention Type
Device
Intervention Name(s)
Zoll Accuvent Ventilation Monitor
Intervention Description
Provides real-time ventilation quality monitoring (rate and volume)
Primary Outcome Measure Information:
Title
Ventilation Volume
Description
Measurement of the volume of ventilation (mL) during resuscitation
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Feasibility of successfully using Zoll Accuvent device in the field Feasibility
Description
Ability to use the Zoll Accuvent during the resuscitation, obtain feedback, and download ventilation information. Feasibility will be defined as >80% success rate.
Time Frame
Day 1
Title
Prehospital Return of spontaneous circulation (ROSC)
Description
any return of circulation in the prehospital setting as documented by paramedics
Time Frame
Day 1
Title
Ventilation Rate
Description
Measure the rate (per minute) of ventilations delivered during resuscitation
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult out-of-hospital cardiac arrests treated by paramedics
Exclusion Criteria:
traumatic cardiac arrest
prehospital Do Not Resuscitate (DNR) orders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheldon Cheskes, MD
Phone
416 667 2200
Ext
0
Email
Sheldon.Cheskes@Sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Drennan, PhD
Phone
416 667 2200
Ext
0
Email
Ian.Drennan@Sunnybrook.ca
Facility Information:
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Drennan, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Ventilation Monitoring in OHCA
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