Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    108
  • sponsor
    Centre Hospitalier Arras
Updated on 26 January 2021

Summary

Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.

A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.

The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.

Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.

Details
Condition Acute Hypercapnic Respiratory Failure
Treatment Under-the-nose facemask, Over-the-nose facemask
Clinical Study IdentifierNCT04102735
SponsorCentre Hospitalier Arras
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute hypercapnic respiratory failure
Initiation of NIV
Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization

Exclusion Criteria

Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
Intubated patient
Patient with a tracheostomy
Post-extubation respiratory failure
Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
Person declining NIV
Pregnancy
Dying person
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