跳至主要内容
临床试验/NCT06572033
NCT06572033招募中不适用

Transference of Established Simulated Skills (TEST) Trial: Tracking Transference of Positive Pressure Ventilation Skills From Simulation to Delivery Room.

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Correlation of mask leak performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Correlation of mask leak performance

时间窗: 1 year

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.

次要结局

  • Correlation of submetrics of VPS(1 year)
  • Correlation of Ventilation Performance Score (VPS)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vishal Kapadia

Associate Professor at UT Southwestern

University of Texas Southwestern Medical Center

研究点 (1)

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