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Completed

NCT Number: NCT04102735

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

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.

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Key information

Conditions

Acute Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Arras, Arras, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Under-the-nose facemask

Device

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.

Over-the-nose facemask

Device

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.

Primary outcomes

  1. Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.

    Time frame: 3 days after NIV initiation

    The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation

Secondary outcomes

  1. Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm

    Time frame: 7 days after NIV initiation

    This secondary endpoint is the delay (in hours) between NIV initiation and the development of a facial pressure ulcer.

  2. Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm

    Time frame: 7 days after NIV initiation

    This secondary endpoint is the highest facial pressure ulcer severity score observed during patient hospitalization. This score is evaluated according to the National Pressure Ulcer Advisory Panel guidelines (Edsberg LE et al., 2016). Stage 1 pressure injury (the less severe score) corresponds to intact skin with a localized area of nonblanchable erythema. Stage 2 pressure injury corresponds to partial-thickness skin loss with exposed dermis. Stage 3 pressure injury corresponds to full-thickness skin loss. Stage 4 pressure injury (the most severe score) corresponds to full-thickness skin and tissue loss.

  3. Change of the patient comfort in the experimental arm, compared to the control arm

    Time frame: 24 hours after NIV initiation

    This secondary endpoint is the comfort patient score at 24 hours after NIV initiation. This score is a numeric scale, validated for NIV (Lemyze M et al., 2013 ; Gregoretti C et al., 2002), going from 1 to 5 (1: very uncomfortable ; 2: uncomfortable ; 3: acceptable ; 4: quite comfortable ; 5: comfortable).

  4. Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm

    Time frame: 7 days after NIV initiation

    This secondary endpoint is the incidence of mask changes related to interface intolerance during patient hospitalization.

  5. Change of the incidence of NIV failure in the experimental arm, compared to the control arm

    Time frame: 7 days after NIV initiation

    This secondary endpoint is the incidence of NIV failure defined as the need to resort to intubation or palliative care (in the case of a do-not-intubate order) during patient hospitalization. NIV failures may be caused by refractory respiratory acidosis, refractory hypoxemia, pressure ulcers, interface intolerance, excessive unintentional air leaks or shock.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Arras

Other

Registry information

Official study title

UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Acronym: UNDER PRESSURE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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