Customized Masks in Non-Invasive Mechanical Ventilation
Spain10 participantsStarted 2023-12-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.