Customized masks for non-invasive ventilation in patients with respiratory conditions
Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing
This study is testing if personalized 3D-printed masks can improve breathing support for people with respiratory conditions like COPD compared to standard masks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid, Comunidad De Madrid) |
| Trial ID | NCT06215391 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of customized 3D-printed masks in improving non-invasive mechanical ventilation (NIMV) for patients with conditions like COPD and ventilatory failure. By utilizing facial scanning and computer-aided design, the study aims to create personalized masks that minimize leakage and upper airway obstruction. Participants will use both a customized mask and a commercial mask over two separate periods, allowing for a comparison of leak levels and overall patient experience. The study focuses on enhancing the quality of ventilation and patient adherence to therapy.
Who should consider this trial
Good fit: Ideal candidates include adults enrolled in a Home Mechanical Ventilation program who use a ResMed device and have specific respiratory conditions.
Not a fit: Patients with tracheostomy, those awaiting lung transplantation, or individuals with allergies to medical-grade silicone components may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the effectiveness of non-invasive ventilation for patients with respiratory conditions.
How similar studies have performed: Previous studies have shown success with personalized masks in other patient populations, indicating potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Comunidad De Madrid
- Hospital Universitarios 12 de Octubre — Madrid, Comunidad De Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Laura Gonzalez Ramos
- Email: lauragramos@hotmail.es
- Phone: 913908492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.