Clinical Trial

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

Completed
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Summary
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.
Trial Details
NCT Number NCT07665164
Lead Sponsor Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborators: Doctors with Africa - CUAMM, Tosamaganga Regional Referral Hospital, National Institute for Medical Research, Tanzania
Conditions Teaching Manual Neonatal Ventilation
Enrollment 79 participants
Start Date 2025-06-17
Primary Completion 2025-06-20 (estimated)
Study Completion 2025-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-24