An interventional study of 3d printed mask in COPD, Severe Early-Onset, Ventilatory Failure and Als, sponsored by Hospital Universitario 12 de Octubre. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Hospital Universitario 12 de Octubre · Not applicable, Interventional, and Treatment
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.
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.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's planned enrollment of 10 is below the median of 52 across 63 interventional studies indexed under Hypoventilation.
Browse Hypoventilation studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Noninvasive ventilation delivered through a conventional mask as usual care
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.
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.
Time frame: 1 month
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
Time frame: 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
Time frame: 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).
Time frame: 1 month
• Polygraphic variables
.1 Asynchrony Index
Time frame: 1 month
PDFs hosted by the registry, ClinicalTrials.gov.
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Hospital Universitario 12 de Octubre