Customized Masks in Non-Invasive Mechanical Ventilation

NCT ID: NCT06215391

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2024-05-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

commercial mask

Noninvasive ventilation delivered through a conventional mask as usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

3d printed mask

Intervention Type: DEVICE

• 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitarios 12 de Octubre

Madrid, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura Gonzalez Ramos

Role: CONTACT

lauragramos@hotmail.es

913908492

Javier Sayas

Role: CONTACT

javier.sayas@salud.madrid.org

+34610989188

Facility Contacts

Javier Sayas

Role: primary

javier.sayas@salud.madrid.org

+34913908492

References

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.

Reference Type: BACKGROUND

PMID: 37048774 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

23/478

Identifier Type: -

Identifier Source: org_study_id