Out-of-hospital Cardiac Arrest (OHCA)VENT-SIMNCT07352709
Ventilation Performance and Feedback Simulation Trial
A study testing Real-time feedback in people with Out-of-hospital Cardiac Arrest (OHCA), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The study "Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial" will address treatments administered by Emergency Medical Services (EMS) during cardiopulmonary resuscitation (CPR) in simulated out-of-hospital cardiac arrest (OHCA). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- Real-time feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >= 18 years
- Credentialed EMS
Who cannot join
- EMS Instructor
- Inactive EMS role
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Betty Yang, MD MS, 214-648-7200, betty.yang@utsouthwestern.edu
Kathryn Naumann, MBA, Kathryn.Naumann@UTSouthwestern, Kathryn.Naumann@UTSouthwestern.edu
About this study
Official title: Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial
The study "Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial" will address treatments administered by Emergency Medical Services (EMS) during cardiopulmonary resuscitation (CPR) in simulated out-of-hospital cardiac arrest (OHCA). The investigators propose a randomized controlled trial among EMS responders to compare quality of rescue breathing performance with and without real-time feedback, along with evaluating CPR strategies (providing rescue breathing during pauses interrupting chest compression vs rescue breathing during uninterrupted chest compressions). The goal of this trial is to learn if visual feedback improves the ability of rescuers to deliver a specified amount of air. The main questions the study aims to answer are:
- Does real-time visual feedback improve ventilation performance and the ability of rescuers to provide a specified amount of air?
- Will different CPR strategies change the effect of feedback on performance? Researchers will compare real-time feedback to no feedback (not showing the visual feedback) to see if real-time feedback works to improve performance.
Read more
Rescuers will:
- Deliver assisted ventilation breaths to a mannequin with and without feedback with two different CPR strategies in one session.
- Fill out a survey about the experience level.
Read the detailed description
The study "Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial" will address treatments administered by Emergency Medical Services (EMS) during cardiopulmonary resuscitation (CPR) in simulated out-of-hospital cardiac arrest (OHCA). Guidelines have recommended delivering assisted rescue breaths at a volume of 500-600 mL or until chest rise. Current standard of practice for CPR strategies is either to deliver 2 rescue breaths during a pause after 30 chest compressions or 1 rescue breath at a rate of 10 breaths per minute during continuous chest compressions. Scientific studies have shown that EMS clinicians have administered rescue breath volumes and rates that can be too high or too low; both extremes can be harmful to patient lungs and outcomes. Despite guideline recommendations on volumes, EMS performance and adherence to specific targets with real-time feedback have not been well tested and compared between the two CPR strategies. Thus, the goal of this trial is to learn if visual feedback improves ventilation performance of rescuers, and assess whether this differs when comparing the two CPR strategies.
The study will address two primary aims:
Aim 1. Test whether adherence to specific targets improves with real-time visual feedback during CPR. The hypothesis is that real-time visual feedback will result in a higher rate of adherence to specific targets.
Aim 2. To compare adherence to specific targets during CPR strategy of 30:2 chest compressions: rescue breaths versus continuous chest compressions and rescue breaths. The hypothesis is that rescue breaths delivered during interrupted chest compressions will result in better compliance with specific targets than those delivered during continuous chest compressions.
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Being tested
- Real-time feedback
- Keywords
- ventilation during resuscitation, CPR, emergency medical services
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time feedbackOther
Visual feedback provided on volumes insufflated and expired
| Study group | Role | What they receive |
|---|---|---|
| Standard CPR with interrupted compressions with feedback | Experimental | Not described Receives: Other: Real-time feedback |
| Standard CPR with interrupted compressions without feedback | No intervention | Not described |
| Continuous chest compressions with feedback | Experimental | Not described Receives: Other: Real-time feedback |
| Continuous chest compressions without feedback | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of guideline compliant ventilations
proportion of ventilations within the target ventilation parameters (tidal volume 500-600 mL)
Measured: 20 minutes
Secondary outcomes (3)
Volume insufflated
Measured: 20 minutes
Volume expired
Measured: 20 minutes
Ventilation rate
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start31 Aug 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Sep 2031 (estimated)
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 Arrest (OHCA)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial with an embedded 2x2 factorial design. We will compare real-time visual feedback (with vs without) primarily and CPR strategy (interrupted compressions and ventilations given during pauses vs continuous compressions and ventilations given interposed). Each provider will serve as their own control and crossover midway on feedback. Each provider will provide ventilations for 5 minutes per arm, for a total of 20 minutes. Each provider will be randomized to the sequence of feedback and CPR strategy, using randomized block design.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Betty Yang, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352709
- Sponsor's protocol ID
- STU20252216
- Acronym
- VENT-SIM
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial
- ClinicalTrials.gov ID
- NCT07352709
- Acronym / sponsor ID
- VENT-SIM / STU20252216
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- ventilation during resuscitation, CPR, emergency medical services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 20 Jan 2026 (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.
The study "Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial" will address treatments administered by Emergency Medical Services (EMS) during cardiopulmonary resuscitation (CPR) in simulated out-of-hospital cardiac arrest (OHCA). The investigators propose a randomized controlled trial among EMS responders to compare quality of rescue breathing performance with and without real-time feedback, along with evaluating CPR strategies (providing rescue breathing during pauses interrupting chest compression vs rescue breathing during uninterrupted chest compressions). The goal of this trial is to learn if visual feedback improves the ability of rescuers to deliver a specified amount of air. The main questions the study aims to answer are:
- Does real-time visual feedback improve ventilation performance and the ability of rescuers to provide a specified amount of air?
- Will different CPR strategies change the effect of feedback on performance? Researchers will compare real-time feedback to no feedback (not showing the visual feedback) to see if real-time feedback works to improve performance.
Rescuers will:
- Deliver assisted ventilation breaths to a mannequin with and without feedback with two different CPR strategies in one session.
- Fill out a survey about the experience level.
Detailed description
The study "Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial" will address treatments administered by Emergency Medical Services (EMS) during cardiopulmonary resuscitation (CPR) in simulated out-of-hospital cardiac arrest (OHCA). Guidelines have recommended delivering assisted rescue breaths at a volume of 500-600 mL or until chest rise. Current standard of practice for CPR strategies is either to deliver 2 rescue breaths during a pause after 30 chest compressions or 1 rescue breath at a rate of 10 breaths per minute during continuous chest compressions. Scientific studies have shown that EMS clinicians have administered rescue breath volumes and rates that can be too high or too low; both extremes can be harmful to patient lungs and outcomes. Despite guideline recommendations on volumes, EMS performance and adherence to specific targets with real-time feedback have not been well tested and compared between the two CPR strategies. Thus, the goal of this trial is to learn if visual feedback improves ventilation performance of rescuers, and assess whether this differs when comparing the two CPR strategies.
The study will address two primary aims:
Aim 1. Test whether adherence to specific targets improves with real-time visual feedback during CPR. The hypothesis is that real-time visual feedback will result in a higher rate of adherence to specific targets.
Aim 2. To compare adherence to specific targets during CPR strategy of 30:2 chest compressions: rescue breaths versus continuous chest compressions and rescue breaths. The hypothesis is that rescue breaths delivered during interrupted chest compressions will result in better compliance with specific targets than those delivered during continuous chest compressions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized crossover trial with an embedded 2x2 factorial design. We will compare real-time visual feedback (with vs without) primarily and CPR strategy (interrupted compressions and ventilations given during pauses vs continuous compressions and ventilations given interposed). Each provider will serve as their own control and crossover midway on feedback. Each provider will provide ventilations for 5 minutes per arm, for a total of 20 minutes. Each provider will be randomized to the sequence of feedback and CPR strategy, using randomized block design.
| Arm | Type | Receives |
|---|---|---|
| Standard CPR with interrupted compressions with feedback | Experimental | Other: Real-time feedback |
| Standard CPR with interrupted compressions without feedback | No intervention | – |
| Continuous chest compressions with feedback | Experimental | Other: Real-time feedback |
| Continuous chest compressions without feedback | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age >= 18 years
- Credentialed EMS
Key exclusion criteria (2 listed)
- EMS Instructor
- Inactive EMS role
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 |
|---|---|---|
| Real-time feedbackVisual feedback provided on volumes insufflated and expired | Other | Continuous chest compressions with feedback, Standard CPR with interrupted compressions with feedback |
Primary outcome
Proportion of guideline compliant ventilations
Time frame: 20 minutes
proportion of ventilations within the target ventilation parameters (tidal volume 500-600 mL)
3 secondary outcomes
Volume insufflated
Time frame: 20 minutes
Volume expired
Time frame: 20 minutes
Ventilation rate
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time feedback in people with Out-of-hospital Cardiac Arrest (OHCA), run by University of Texas Southwestern Medical Center at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betty Yang, MD MS (214-648-7200, betty.yang@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of guideline compliant ventilations (time frame: 20 minutes). 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 3 Sep 2026.