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临床试验/NCT07665164
NCT07665164已完成不适用

Experimental Study and Training for Tanzanian Students and Health Professionals With a New Simulator for Manual Neonatal Ventilation

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2025年6月17日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to build capacity and assess the teaching effectiveness of a new simulator for manual neonatal ventilation in third-year nursing and clinical officer students, as well as healthcare professionals from the neonatology, gynecology, and pediatric departments.

The main questions it aims to answer are:

  • Does the high-fidelity active setup of the simulator improve the percentage of target pressure achieved and the mean ventilation frequency compared to other configurations?
  • How do different simulator configurations affect the training outcomes of unexperienced and experienced personnel, based on objective evaluations by expert clinicians and knowledge surveys?
  • What is the self-reported usability and perceived usefulness of the different simulator configurations among the trainees? Researchers will compare a medium-fidelity passive setup, a high-fidelity passive setup with mechanical feedback, and a high-fidelity active setup with both mechanical and sensor feedback to see if the high-fidelity active configuration results in significantly higher clinical performance scores and better achievement of ventilation targets.

Participants will:

  • Attend theoretical frontal lectures covering manual emergency ventilation procedures and medical simulation.
  • Complete pre-training and post-training surveys to assess baseline knowledge, evaluate acquired skills, and report on the simulator's usability.
  • Participate in hands-on simulator training, practicing the clinical procedure (positioning the newborn, positioning the mask, and ventilating) three times.
  • Undergo a final simulation session for evaluation, where performance is objectively scored by a tutor and automatically recorded by the simulator's sensors.

详细描述

Background and Rationale

Neonatal mortality in sub-Saharan Africa remains disproportionately high-26 deaths per 1,000 live births in 2023, which is 8.7 times higher than rates in Europe and North America. A significant portion of these deaths are attributable to preventable and treatable conditions occurring during birth. While skilled birth attendance can prevent up to 40% of neonatal deaths, assistance rates in sub-Saharan Africa are drastically low (40%) compared to high-income countries (90%). Consequently, strengthening the capacity of the health workforce to deliver essential newborn care is a critical priority.

Neonatal resuscitation is a complex, time-sensitive procedure. Due to severe limitations in access to advanced respiratory technologies in these regions, manual ventilation using a self-inflating bag and face mask constitutes the primary method of respiratory support. Because manual ventilation is highly operator-dependent and can cause substantial harm if performed incorrectly, technical proficiency is paramount. Simulation-based training is internationally recommended to improve provider competence, yet data on the real-world implementation, acceptability, and educational effectiveness of low-cost, high-fidelity simulators tailored to low-resource settings remains limited. This study evaluates a newly designed simulator developed specifically for the Tanzanian environment to ensure healthcare workers can acquire and maintain resuscitation skills.

Study Objectives

The specific objectives of this study are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Third-year nursing students enrolled at the Tosamaganga Institute of Health and Allied Sciences (TIHAS).
  • Third-year clinical officer students enrolled at TIHAS.
  • Healthcare professionals working at Tosamaganga Hospital within the neonatology, gynecology, midwifery, and pediatrics departments.
  • Individuals who voluntarily choose to attend the course.

排除标准

  • Healthcare professionals working in fields outside of nursing, gynecology, midwifery, neonatology, and pediatrics.
  • Participants who fail to complete the full training program, either by not attending all sessions or by prematurely withdrawing from the course.

研究者

发起方
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arianna Menciassi

Professor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

研究点 (1)

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