Transference of Established Simulated Skills (TEST) Trial

Running, not enrolling

Conditions studied: Neonatal Respiratory Distress

In brief

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.

Key facts

Study ID

NCT06572033

Run by

University of Texas Southwestern Medical Center

People needed

120

Starts

2024-08-12

Expected to finish

2026-06-29

Last updated by the study team

2026-03-25

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Inclusion and Exclusion Criteria for Newborn Infants
• Inclusion Criteria:
• 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:
• 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.

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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