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

Not Applicable

Completed

• Conditions: Acute Hypercapnic Respiratory Failure
• Interventions: Device: Over-the-nose facemask; Device: Under-the-nose facemask

• Registration Number: NCT04102735
• Lead Sponsor: Centre Hospitalier Arras

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-21
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Primary Completion: 2021-10-03
• Study Completion: 2021-10-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Over-the-nose facemask	Over-the-nose facemask	The AF541 oro-nasal mask is used with the over-the-nose mask cushion.
Under-the-nose facemask	Under-the-nose facemask	The AF541 oro-nasal mask is used with the under-the-nose mask cushion.

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier Lens; 🇫🇷 Lens, France

Centre Hospitalier Arras; 🇫🇷 Arras, France