Experimental Study and Training for Tanzanian Students and Health Professionals With a New Simulator for Manual Neonatal Ventilation
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
- 是
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
Arianna Menciassi
Professor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
