Clinical trial NCT06215391: Customized Masks in Non-Invasive Mechanical Ventilation
Official title: Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD, Severe Early-Onset
Ventilatory Failure
Als
Non Invasive Ventilation
Keywords: non invasive ventilation
3d printed mask
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Conceptual Hypothesis:

The use of personalized 3D-printed masks may reduce leaks, adverse effects in the form of skin lesions, and the percentage of upper airway obstructive events in two distinct populations: patients with ALS and patients with COPD requiring inspiratory pressures greater than 22 cmH2O.

Operational Hypothesis:

The automatic AHI and the median leaks over 1 month are lower when the patient uses the custom-fit 3D-printed mask (M3D) compared to when they use the commercial mask (MC) that was prescribed.

Statistical Hypothesis:

H0: There are no differences in the median leaks over 1 month (and AHI) between commercial masks (MC) and personalized 3D-printed masks (M3D).

H1: The median leaks are significantly lower during the month of using the personalized mask (M3D) than during the use of the commercial mask.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modifications in leaks
timeFrame: 1 month
Secondary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 1 month
measure: Comfort
timeFrame: 1 month
measure: Adherence
timeFrame: 1 month
measure: • Polygraphic variables
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitarios 12 de Octubre
state: Comunidad De Madrid
Study officials:
References:
citation: 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.