Transference of Established Simulated Skills (TEST) Trial

NCT ID: NCT06572033

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2025-12-29

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.

Detailed Description

Objectives: The aim of this study is to establish evidence that supports the transfer of skills learned in the simulation lab to the delivery room. The objective of this study is to compare the performance of positive pressure ventilation (PPV) in the simulation lab to the performance of the same individual in the delivery room. Our goal is to establish a comparison between parameters measured on the simulator and those obtained from real newborn infants, specifically looking at mask leak. Our approach hopes to develop a ventilation performance score (VPS) in the process that will be based on objective data collected using a respiratory function monitor (RFM). The primary hypothesis is that the quality of a qualified provider's ability to circumvent mask leak on a mannequin correlates with the ability of the same provider to circumvent mask leak observed on a newborn infant.

Design and outcomes: TEST Trial is a prospective observational study to assess differences in the participants ability to avoid mask leak while performing PPV and in the process allow the investigators to develop a ventilatory performance score in the simulation lab and the delivery room. We will use the RFM Monivent Neo100 to gather PPV data in both the simulation lab from the mannequins and newborns in the delivery room. The study will compare mask leak as well as VPS in the simulation room to mask leak and VPS in the delivery room to assess for correlations. In addition, the investigators will conduct secondary analysis on each individual domain of positive pressure ventilation, such as PIP, PEEP, eVT, etc.

Conditions

Neonatal Respiratory Distress

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Simulation

Intervention Type: BEHAVIORAL

Observational study with simulations.

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.

No interventions assigned to this group

Interventions

Simulation

Observational study with simulations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Respiratory Therapists who are employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital.
• RTs who actively participate in neonatal deliveries.

• 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.

Exclusion Criteria

• 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.

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vishal Kapadia

Associate Professor at UT Southwestern

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Efren Diaz, MD

Role: CONTACT

efren.diaz@utsouthwestern.edu

3054986985

Vishal Kapadia, MD

Role: CONTACT

vishal.kapadia@utsouthwestern.edu

2174942554

Facility Contacts

Efren Diaz, MD

Role: primary

efren.diaz@utsouthwestern.edu

3054986985

Vishal Kapadia, MD

Role: backup

vishal.kapadia@utsouthwestern.edu

2174942554

Other Identifiers

STU 2023-1099

Identifier Type: -

Identifier Source: org_study_id