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Ventilation Performance and Feedback Simulation Trial (VENT-SIM)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Begins enrollment this month

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Treatments

Other: Real-time feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT07352709
STU20252216

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >= 18 years
  • Credentialed EMS

Exclusion criteria

  • EMS Instructor
  • Inactive EMS role

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Standard CPR with interrupted compressions with feedback
Experimental group
Treatment:
Other: Real-time feedback
Standard CPR with interrupted compressions without feedback
No Intervention group
Continuous chest compressions with feedback
Experimental group
Treatment:
Other: Real-time feedback
Continuous chest compressions without feedback
No Intervention group

Trial contacts and locations

1

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Central trial contact

Betty Yang, MD MS; Kathryn Naumann, MBA

Data sourced from clinicaltrials.gov

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