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

  • End date
    Jun 27, 2022
  • participants needed
  • sponsor
    Centre Hospitalier Arras
Updated on 27 September 2021


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.

Condition Acute Hypercapnic Respiratory Failure
Treatment Under-the-nose facemask, Over-the-nose facemask
Clinical Study IdentifierNCT04102735
SponsorCentre Hospitalier Arras
Last Modified on27 September 2021


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
Dying person
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note