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Customized Masks in Non-Invasive Mechanical Ventilation

NCT06215391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-22

No results posted yet for this study

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.

Conditions

  • COPD, Severe Early-Onset
  • Ventilatory Failure
  • Als
  • Non 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.

Sponsors & Collaborators

  • Hospital Universitario 12 de Octubre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2024-04-30
Completion
2024-05-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215391 on ClinicalTrials.gov