What question did this study set out to answer?

The study aims to compare the effectiveness of three protective devices in preventing skin injuries during noninvasive ventilation in patients with acute respiratory failure.

May 19, 2026Open Access

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

Key Points

The study aims to compare the effectiveness of three protective devices in preventing skin injuries during noninvasive ventilation in patients with acute respiratory failure.
Multicenter, randomized, open-label, controlled trial across 15 intensive care units in Italy and Spain.
Eligible patients with hypoxemic or mixed hypoxemic-hypercapnic acute respiratory failure will be randomly assigned to one of four groups.
Participants will receive either Tegaderm®, Duoderm®, Allevyn Adhesive®, or standard care, with outcomes evaluated using standardized scoring systems.
The primary endpoint is skin injury-free survival, with comparisons among the different protective devices based on lesion grading and pain assessment.
Secondary endpoints include device stability, patient comfort, timing of skin lesions, and overall efficacy of noninvasive ventilation.

Abstract

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. 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. 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. 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. NCT01351155.

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