Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT06572033
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.
Study:
NCT06572033
Study Brief:
Protocol Section:
NCT06572033