Customized Masks in Non-Invasive Mechanical Ventilation

Als Clinical Trial

Official title: Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing

Status Recruiting

Clinical Trial Summary

In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. It will focus on ventilator registries and changes in the way they can be corrected with these customised masks. The process involves 3D face scanning and dedicated computer-aided design. The processing and manufacturing of the masks is based on additive manufacturing through 3D printing.

Clinical Trial Description

In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and the quality of therapy depend mainly on it. A deteriorated or inadequate mask can lead to unintentional leaks or jaw and tongue displacements, thereby increasing obstructive events in the upper airway. There is a growing interest in the use of personalized masks designed using facial scanning and 3D printing technology. Previous studies have demonstrated their effectiveness in complex patients, such as premature neonates, and healthy individuals, successfully reducing leaks and skin sores. The aim of the project is to demonstrate the utility of a 3D-printed, customised mask to improve the quality of ventilation, primarily by reducing leaks and mask-related obstructions in adult patients receiving home NIMV. Two usage periods of NIMV will be studied, one month with a personalized mask created through 3D printing (M3D) and another month with a commercial mask (MC). The primary variable under study will be the difference in leak levels between M3D and MC throughout the study month with each of them. Variables derived from respiratory polygraphy, performed with each mask, will also be included, in addition to the patient's experience. ;

Related Conditions & MeSH terms

• Als
• COPD, Severe Early-Onset
• Hypoventilation
• Non Invasive Ventilation
• Ventilatory Failure

• NCT number: NCT06215391
• Study type: Interventional
• Source: Hospital Universitario 12 de Octubre
• Contact: Laura Gonzalez Ramos
• Phone: 913908492
• Email: lauragramos@hotmail.es
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Completion date: May 2024