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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Under-the-nose facemask
* Device: Over-the-nose facemask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Over-the-nose facemask<br>The AF541 oro-nasal mask is used with the over-the-nose mask cushion. | Device: Over-the-nose facemask<br>* 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.<br>|
| Experimental: Under-the-nose facemask<br>The AF541 oro-nasal mask is used with the under-the-nose mask cushion. | Device: Under-the-nose facemask<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial pressure ulcers, noninvasive ventilation, acute hypercapnic respiratory failure