Comparison of Three Devices Preventing Skin Damage During Facial Mask Ventilation in Acute Respiratory Failure: Multicenter Randomized Controlled Trial Protocol (3PROSNIVtrial)

Abstract

BACKGROUND: In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), pressure-related skin injury is among the most frequent and clinically relevant complications. The reported prevalence of device-related pressure injuries is estimated at around 25%, while reported incidences of NIV-related facial pressure ulcers range from approximately 10-31%. These lesions, mainly localized over the nasal bridge, arise because the skin in this area is thin and supported by minimal subcutaneous tissue, making it highly vulnerable to ischemic and frictional forces exerted by the mask interface. In severe cases, skin breakdown may lead to pain, infection, or discontinuation of NIV, thereby compromising ventilatory support. The most commonly adopted preventive strategy involves the application of shaped hydrocolloid dressings; however, evidence regarding their actual effectiveness and the potential benefits of alternative protective devices remains limited. OBJECTIVES: The primary aim of this study is to compare skin injury-free survival in ARF patients receiving NIV treated with three different CE-marked protective systems. Secondary objectives include assessing device stability and protective performance, patient comfort, pain intensity, mask tolerance, timing and staging of skin lesions, cost-effectiveness, predictive factors for skin injury, and overall NIV success. METHODS: This is a multicenter, randomized, open-label, controlled trial involving 14 Italian pulmonology intensive care units and 1 Spanish Intensive Care Unit. Eligible patients with hypoxemic or mixed hypoxemic-hypercapnic ARF requiring NIV for more than 24 h will be randomly assigned to one of four study arms (three intervention groups and one control group). Each group will receive a different protective device-Tegaderm(®), Duoderm(®), or Allevyn Adhesive(®)-or standard care. Lesion grading, pain assessment, and device performance will be evaluated using standardized scoring systems. PLANNED OUTCOMES: The trial will provide comparative evidence on the efficacy of different protective dressings in preventing NIV-related facial skin injury, thereby supporting the development of evidence-based recommendations for clinical practice. TRIAL REGISTRATION: NCT01351155.