Customized Masks in Non-Invasive Mechanical Ventilation

Not Applicable

Recruiting

• Conditions: Als; Non Invasive Ventilation; Ventilatory Failure; COPD, Severe Early-Onset
• Interventions: Device: 3d printed mask

• Registration Number: NCT06215391
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-10
• Study Start: 2023-12-10
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3d printed mask	3d printed mask	The customized mask will be obtained by merging the scanned surface with the base mask design using CAD 3D SolidWorks software, also available in the unit. In patients with edentulism, leak areas will be evaluated without dental prostheses. 3D Printing Personalized oronasal masks will be manufactured following this procedure: * Design and manufacture of molds for each type of base mask and the personalized mold of the scanned surface, using stereolithography technology with suitable biocompatible resin such as BioMed Clear or White from FormLABS. * Manual injection of a biocompatible resin with a Shore A hardness of 18, such as SORTA-Clear™ 18, by joining the two molds. This Shore A hardness will provide appropriate elasticity for this type of mask, perfectly adapting to each patient's unique facial characteristics.

Primary Outcome Measures

Name	Time	Method
Modifications in leaks	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.

Secondary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	1 month	• Mean AHI over the study month with each mask, automatically recorded by the respirator software (ResScan®) for each mask period. IAH /AHI ranges from 0 to over 30 events per hour. A threshold of \<10 is usually considered a sign of adequate ventilation. A minimal decrease of 20% will be considered clinically relevant
• Polygraphic variables	1 month	.1 Asynchrony Index
Adherence	1 month	• Adherence measured by the mean device usage (hours of use/days of use) and total days of use in 1 month (T0 vs. T1).
Comfort	1 month	• Patient comfort at the end of the one-month period with each mask (Likert scale). Likert scale ranges from Strongly uncomfortable to strongly comfortable

Trial Locations

Locations (1)

Hospital Universitarios 12 de Octubre; 🇪🇸 Madrid, Comunidad De Madrid, Spain