Ventilation Performance and Feedback Simulation Trial

NCT07352709 | Not Yet Recruiting

• 1 other identifier: STU20252216
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Keywords

ventilation during resuscitation; CPR; emergency medical services

Outcome Measures

Primary Outcomes (1)

• Proportion of guideline compliant ventilations

  proportion of ventilations within the target ventilation parameters (tidal volume 500-600 mL)

  20 minutes

Secondary Outcomes (3)

• Volume insufflated

  20 minutes

• Volume expired

  20 minutes

• Ventilation rate

  20 minutes

Study Arms (4)

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

Interventions

Real-time feedback OTHER

Visual feedback provided on volumes insufflated and expired

Continuous chest compressions with feedback; Standard CPR with interrupted compressions with feedback

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>= 18 years
• Credentialed EMS

You may not qualify if:

• EMS Instructor
• Inactive EMS role

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Betty Yang, MD MS

CONTACT

214-648-7200; betty.yang@utsouthwestern.edu

Kathryn Naumann, MBA

CONTACT

214-648-7200; Kathryn.Naumann@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

US (1)