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

NCT04102735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-03-15

No results posted yet for this study

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.

Conditions

  • Acute Hypercapnic Respiratory Failure

Interventions

DEVICE

Under-the-nose facemask

Patients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion.

DEVICE

Over-the-nose facemask

Patients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion.

Sponsors & Collaborators

  • Centre Hospitalier Arras

    lead OTHER

Principal Investigators

  • Malcolm LEMYZE, MD · Centre Hospitalier Arras

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2021-10-03
Completion
2021-10-03

Countries

  • France

Study Locations

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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 NCT04102735 on ClinicalTrials.gov