Customized Masks in Non-Invasive Mechanical Ventilation

NCT06215391 | Unknown

• 1 other identifier: 23/478
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

non invasive ventilation; 3d printed mask

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Apnea Hypopnea Index

  1 month

• Comfort

  1 month

• Adherence

  1 month

• • Polygraphic variables

  1 month

Study Arms (2)

commercial mask

NO INTERVENTION

Noninvasive ventilation delivered through a conventional mask as usual care

3d printed mask

EXPERIMENTAL

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

Interventions

3d printed mask 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.

3d printed mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Hospital Universitarios 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Related 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.

  PMID: 37048774 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive, Severe Early-Onset; Hypoventilation; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Laura Gonzalez Ramos

CONTACT

913908492; lauragramos@hotmail.es

Javier Sayas

CONTACT

+34610989188; javier.sayas@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: January 22, 2024
• Study Start: December 10, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

ES (1)