Customized Masks in Non-Invasive Mechanical Ventilation

Launched by HOSPITAL UNIVERSITARIO 12 DE OCTUBRE · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of customized mask designed for people who need non-invasive mechanical ventilation (NIMV) to help with breathing difficulties, particularly those with conditions like COPD or ALS. The goal is to see if these specially designed masks can reduce air leakage and improve the comfort and effectiveness of the breathing support provided by the ventilator. The masks are created using advanced 3D scanning and printing technology, which allows them to fit each person's face more snugly and securely.

To participate in this study, you need to be enrolled in a Home Mechanical Ventilation program and use a specific type of ventilator made by ResMed for at least four hours a day. You should have a certain level of breathing pressure needs and experience some air leakage with your current mask. However, patients who have had a tracheostomy, are waiting for a lung transplant, or have certain allergies cannot join. If you are eligible and decide to take part, you’ll receive a custom mask tailored just for you, and the researchers will monitor how well it works in improving your ventilation experience. This trial aims to provide better solutions for those who rely on mechanical ventilation at home.

Gender

ALL

Eligibility 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.