Customized Masks in Non-Invasive Mechanical Ventilation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non Invasive Ventilation; Ventilatory Failure; COPD, Severe Early-Onset; Als
• Intervention / Treatment: Device: 3d printed mask

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Gonzalez Ramos; Phone Number: 913908492; Email: lauragramos@hotmail.es
• Study Contact Backup: Name: Javier Sayas; Phone Number: +34610989188; Email: javier.sayas@salud.madrid.org

Study Locations

• Spain
  • Comunidad De Madrid
    • Madrid, Comunidad De Madrid, Spain, 28041
      • Recruiting
      • Hospital Universitarios 12 de Octubre
      • Contact: Javier Sayas; Phone Number: +34913908492; Email: javier.sayas@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: commercial mask; Noninvasive ventilation delivered through a conventional mask as usual care
Experimental: 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.	Device: 3d printed mask; Concurrent, prospective, non-randomized inclusion, cross-over design. A minimum of 6 patients will be included for each group, COPD, and ALS.; T0: Patient enrollment (informed consent signing), retrospective review of the respirator log (1 month prior), variable extraction (extracting EDF files from the respirator log and data obtained from ResScan).; During the first week, a 3D scan of the patient's face will be conducted, and the personalized 3D-printed mask (M3D) will be manufactured.; Once ready, the mask will be fitted, and the 1-month evaluation period will begin (T1: after 1 month of M3D use). The respirator card will be downloaded in the same manner as at T0, and a respiratory polygraphy (RP) will be scheduled.; T2: At the end of the study month, the patient will resume using a similar MC, which is new and well-fitted. After one month of MC use, the respirator log will be reviewed, and a new RP will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifications in leaks	Median daily leakage over the study month with each mask (MC and M3D), determined from the respirator log, extracted using ResScan® (Resmed®) software.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index	• 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	1 month
Comfort	• Patient comfort at the end of the one-month period with each mask (Likert scale). Likert scale ranges from Strongly uncomfortable to strongly comfortable	1 month
Adherence	• Adherence measured by the mean device usage (hours of use/days of use) and total days of use in 1 month (T0 vs. T1).	1 month
• Polygraphic variables	.1 Asynchrony Index	1 month

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre

Publications and helpful links

General Publications

• Lujan M, Florez P, Pomares X. What Circuits, Masks and Filters Should Be Used in Home Non-Invasive Mechanical Ventilation. J Clin Med. 2023 Apr 4;12(7):2692. doi: 10.3390/jcm12072692.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: non invasive ventilation; 3d printed mask
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: 23/478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No