Customized Masks in Non-Invasive Mechanical Ventilation

Als Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215391
• Other study ID #: 23/478
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Hospital Universitario 12 de Octubre
• Contact: Laura Gonzalez Ramos
• Phone: 913908492
• Email: lauragramos[@]hotmail.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitarios 12 de Octubre	Madrid	Comunidad De Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	• Polygraphic variables	.1 Asynchrony Index	1 month