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

Centre Hospitalier Arras

Status: Completed

Conditions: Acute Hypercapnic Respiratory Failure

Treatments: Device: Over-the-nose facemask; Device: Under-the-nose facemask

Study type: Interventional

Funder types: Other

Identifiers

NCT04102735

2017-02

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Over-the-nose facemask

Active Comparator group

Description:

The AF541 oro-nasal mask is used with the over-the-nose mask cushion.

Treatment:

Device: Over-the-nose facemask

Under-the-nose facemask

Experimental group

Description:

The AF541 oro-nasal mask is used with the under-the-nose mask cushion.

Treatment:

Device: Under-the-nose facemask