Ventilation Performance and Feedback Simulation Trial (VENT-SIM)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Out-of-hospital Cardiac Arrest (OHCA)
• Intervention / Treatment: Other: Real-time feedback

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betty Yang, MD MS; Phone Number: 214-648-7200; Email: betty.yang@utsouthwestern.edu
• Study Contact Backup: Name: Kathryn Naumann, MBA; Phone Number: 214-648-7200; Email: Kathryn.Naumann@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Contact: Betty Yang, MD MS; Phone Number: 214-648-7200; Email: betty.yang@utsouthwestern.edu
      • Contact: Kathryn Naumann, MBA; Phone Number: Kathryn.Naumann@UTSouthwestern; Email: Kathryn.Naumann@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 18 years
• Credentialed EMS

Exclusion Criteria:

• EMS Instructor
• Inactive EMS role

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard CPR with interrupted compressions with feedback	Other: Real-time feedback; Visual feedback provided on volumes insufflated and expired
No Intervention: Standard CPR with interrupted compressions without feedback
Experimental: Continuous chest compressions with feedback	Other: Real-time feedback; Visual feedback provided on volumes insufflated and expired
No Intervention: Continuous chest compressions without feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of guideline compliant ventilations	proportion of ventilations within the target ventilation parameters (tidal volume 500-600 mL)	20 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Volume insufflated	20 minutes
Volume expired	20 minutes
Ventilation rate	20 minutes

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CPR; emergency medical services; ventilation during resuscitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: STU20252216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No