Out-Of-Hospital Cardiac ArrestNCT04988906
Ventilation Monitoring in OHCA
A study testing Zoll Accuvent Ventilation Monitor in people with Out-Of-Hospital Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Zoll Accuvent Ventilation Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2021to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult out-of-hospital cardiac arrests treated by paramedics
Who cannot join
- traumatic cardiac arrest
- prehospital Do Not Resuscitate (DNR) orders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Ventilations During Out-of-Hospital Cardiac Arrest Resuscitation
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).
Read the 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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Zoll Accuvent Ventilation Monitor
- Keywords
- Ventilation, Cardiac Arrest, Resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Respiratory Aspiration, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoll Accuvent Ventilation MonitorDevice
Provides real-time ventilation quality monitoring (rate and volume)
| Study group | Role | What they receive |
|---|---|---|
| Before Arm | No intervention | 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. |
| After Arm | Active comparator | 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. Receives: Device: Zoll Accuvent Ventilation Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Volume
Measurement of the volume of ventilation (mL) during resuscitation
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1
Prehospital Return of spontaneous circulation (ROSC)
any return of circulation in the prehospital setting as documented by paramedics
Measured: Day 1
Ventilation Rate
Measure the rate (per minute) of ventilations delivered during resuscitation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start10 Aug 2021
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before-and-After Design
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Prescott-Russell Paramedic Service, Peterborough Paramedic Service, Bruce County Paramedic Service, Waterloo Paramedic Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988906
- Sponsor's protocol ID
- 1987
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Ventilations During Out-of-Hospital Cardiac Arrest Resuscitation
- ClinicalTrials.gov ID
- NCT04988906
- Acronym / sponsor ID
- 1987
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Ventilation, Cardiac Arrest, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Prescott-Russell Paramedic Service, Peterborough Paramedic Service, Bruce County Paramedic Service, Waterloo Paramedic Service
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-and-After Design
| Arm | Type | Receives |
|---|---|---|
| Before Arm | No intervention | –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. |
| After Arm | Active comparator | Device: Zoll Accuvent Ventilation MonitorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult out-of-hospital cardiac arrests treated by paramedics
Key exclusion criteria (2 listed)
- traumatic cardiac arrest
- prehospital Do Not Resuscitate (DNR) orders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoll Accuvent Ventilation MonitorProvides real-time ventilation quality monitoring (rate and volume) | Device | After Arm |
Primary outcome
Ventilation Volume
Time frame: Day 1
Measurement of the volume of ventilation (mL) during resuscitation
3 secondary outcomes
Feasibility of successfully using Zoll Accuvent device in the field Feasibility
Time frame: Day 1
Prehospital Return of spontaneous circulation (ROSC)
Time frame: Day 1
Ventilation Rate
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoll Accuvent Ventilation Monitor in people with Out-Of-Hospital Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Volume (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.