Transference of Established Simulated Skills (TEST) Trial

NCT06572033 | Active Not Recruiting DMC

• 1 other identifier: STU 2023-1099
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. By comparing the performance of healthcare providers on mannequins in the lab to their performance on newborns in the delivery room, the study seeks to establish a Ventilation Performance Score (VPS) based on data from a respiratory function monitor. The primary hypothesis is that a provider's ability to minimize mask leak on a mannequin correlates with their ability to do so with a newborn. The prospective observational TEST Trial will use the Monivent Neo100 to collect and analyze PPV data, comparing key parameters like mask leak and VQS between the two settings to assess correlations. Secondary analysis will explore individual aspects of PPV, such as PIP, PEEP, and eVT.

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• Correlation of mask leak performance

  Correlation between the percentage of mask leak observed during positive pressure ventilation (PPV) on a mannequin in the simulation laboratory and the percentage of mask leak observed during PPV on a newborn infant in the delivery room.

  1 year

Secondary Outcomes (2)

• Correlation of Ventilation Performance Score (VPS)

  1 year

• Correlation of submetrics of VPS

  1 year

Study Arms (2)

Respiratory Therapists

This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios.

Behavioral: Simulation

Newborn Infants

This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios.

Interventions

Simulation BEHAVIORAL

Observational study with simulations.

Respiratory Therapists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Respiratory Therapists (RTs): Demographics: This group includes Respiratory Therapists employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital. Participants have varying levels of experience, ranging from newly certified RTs to those with extensive experience in neonatal care. 2. Newborn Infants: Demographics: This group includes newborn infants requiring positive pressure ventilation (PPV) immediately after birth in the delivery room. Infants included in the study will vary in gestational age, birth weight, and clinical condition, representing a broad range of neonatal resuscitation scenarios.

You may not qualify if:

• Respiratory Therapists who are employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital.
• RTs who actively participate in neonatal deliveries.
• Respiratory Therapists classified as "float" RTs, meaning those who do not have a permanent assignment in the NICU.
• RTs who intend to leave the institution within the upcoming year.
• Newborn infants who require positive pressure ventilation (PPV) immediately after birth in the delivery room.
• Infants of various gestational ages and birth weights, representing a broad spectrum of neonatal resuscitation scenarios.
• Newborns who do not require PPV after birth.
• Infants for whom the use of the respiratory function monitor (RFM) is not feasible due to medical or technical reasons.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at UT Southwestern

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: August 12, 2024
• Primary Completion: December 29, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-07

Locations

US (1)