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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: Over-the-nose facemask; Device: Under-the-nose facemask

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Arras, France
    • Centre Hospitalier ARRAS
  • Lens, France
    • Centre Hospitalier Lens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Over-the-nose facemask; The AF541 oro-nasal mask is used with the over-the-nose mask 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.
EXPERIMENTAL: Under-the-nose facemask; The AF541 oro-nasal mask is used with the under-the-nose mask cushion.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation	3 days after NIV initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm	This secondary endpoint is the delay (in hours) between NIV initiation and the development of a facial pressure ulcer.	7 days after NIV initiation
Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm	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.	7 days after NIV initiation
Change of the patient comfort in the experimental arm, compared to the control arm	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).	24 hours after NIV initiation
Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm	This secondary endpoint is the incidence of mask changes related to interface intolerance during patient hospitalization.	7 days after NIV initiation
Change of the incidence of NIV failure in the experimental arm, compared to the control arm	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.	7 days after NIV initiation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Arras

Publications and helpful links

General Publications

• Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
• Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.
• Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamna F, Nava S, Calderini E, Skrobik Y, Antonelli M. Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med. 2002 Mar;28(3):278-84. doi: 10.1007/s00134-002-1208-7. Epub 2002 Feb 6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2018
• Primary Completion (ACTUAL): October 3, 2021
• Study Completion (ACTUAL): October 3, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: noninvasive ventilation; facial pressure ulcers; acute hypercapnic respiratory failure
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Respiration Disorders; Skin Ulcer; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Pressure Ulcer; Hypercapnia
• Other Study ID Numbers: 2017-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No