Status:
RECRUITING
Customized Masks in Non-Invasive Mechanical Ventilation
Lead Sponsor:
Hospital Universitario 12 de Octubre
Conditions:
COPD, Severe Early-Onset
Ventilatory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and the quality of therapy depend mainly on it. A deteriorated or inadequate mask can l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06215391
Start Date
December 10 2023
End Date
May 1 2024
Last Update
January 22 2024
Active Locations (1)
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1
Hospital Universitarios 12 de Octubre
Madrid, Madrid, Spain, 28041