Customized Masks in Non-Invasive Mechanical Ventilation

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 10, 2023

Primary Completion Date

April 30, 2024

Study Completion Date

May 31, 2024

Conditions
COPD, Severe Early-OnsetVentilatory FailureAlsNon Invasive Ventilation
Interventions
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."

Trial Locations (1)

28041

RECRUITING

Hospital Universitarios 12 de Octubre, Madrid

All Listed Sponsors
lead

Hospital Universitario 12 de Octubre

OTHER