Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Modifications in leaks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled in the Home Mechanical Ventilation (HMV) program.
- •Adherence of >4 hours per day.
- •In the case of COPD, inspiratory pressures >18 cmH2O.
- •Users of a Resmed HMV device to standardize and facilitate the analysis of the respirator log.
- •Commercial masks (MC) in optimal condition, as assessed by the mechanical ventilation unit responsible during outpatient ventilation consultations.
- •Presence of residual leaks (>5 LPM on average according to the respirator log - ResScan, unintentional leaks, with intentional leaks excluded by software).
排除标准
- •Patients with tracheostomy or scheduled for tracheostomy.
- •Patients on a waiting list for lung transplantation.
- •Patients using HMV devices from manufacturers other than ResMed.
- •Users who alternate between various MC models, where homogeneity in interface use cannot be assured.
- •Refusal to provide consent.
- •Patients with documented allergies to components of medical-grade silicone used in the production of M3D.
- •Exacerbations requiring hospitalization or changes in medication or the respirator in the last 3 months.
结局指标
主要结局
Modifications in leaks
时间窗: 1 month
Median daily leakage over the study month with each mask (MC and M3D), determined from the respirator log, extracted using ResScan® (Resmed®) software.
次要结局
- Apnea Hypopnea Index(1 month)
- • Polygraphic variables(1 month)
- Adherence(1 month)
- Comfort(1 month)