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Not yet recruiting NCT07352709

Ventilation Performance and Feedback Simulation Trial

No phase Interventional Out-of-hospital Cardiac Arrest (OHCA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Real-time feedback.
Who it may be relevant to
Registry conditions: Out-of-hospital Cardiac Arrest (OHCA). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Understanding the Effect of Feedback on Ventilation Performance of Rescuers in a Simulation Trial

Overview

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.

Interventions

  • Other Real-time feedback
    Visual feedback provided on volumes insufflated and expired

Primary outcome measures

  • Proportion of guideline compliant ventilations [Time frame: 20 minutes]
Secondary outcome measures (3)
  • Volume insufflated [Time frame: 20 minutes]
  • Volume expired [Time frame: 20 minutes]
  • Ventilation rate [Time frame: 20 minutes]

Eligibility criteria

Inclusion criteria

  • Age >= 18 years
  • Credentialed EMS

Exclusion criteria

  • EMS Instructor
  • Inactive EMS role

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT07352709 · STU20252216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗