Comparison of Three Devices Preventing Skin Damage During Facial Mask Ventilation in Acute Respiratory Failure:...

Area of Science:

• Critical Care Medicine
• Pulmonology
• Dermatology

Background:

• Noninvasive ventilation (NIV) for acute respiratory failure (ARF) frequently causes skin injuries, with reported prevalence of 25% for device-related pressure injuries and 10-31% for facial pressure ulcers.
• These lesions, often on the nasal bridge, result from mask interface pressure and friction on vulnerable skin, potentially leading to pain, infection, or NIV cessation.
• Current preventive strategies, like hydrocolloid dressings, lack robust evidence, highlighting a need for comparative studies on alternative protective devices.

Purpose of the Study:

• To compare skin injury-free survival among ARF patients undergoing NIV with three different CE-marked protective systems versus standard care.
• To evaluate secondary outcomes including device stability, patient comfort, pain, mask tolerance, lesion characteristics, cost-effectiveness, and predictors of skin injury.

Main Methods:

• A multicenter, randomized, open-label, controlled trial conducted in 15 intensive care units (14 Italian, 1 Spanish).
• Patients with ARF requiring NIV >24 hours were randomized into four arms: three groups received different protective devices (Tegaderm®, Duoderm®, Allevyn Adhesive®), and one control group received standard care.
• Standardized scoring systems were used to assess lesion grading, pain, and device performance.

Main Results:

• This section is based on planned outcomes as the study is likely ongoing or recently completed and full results are not yet published.
• The trial is designed to provide comparative evidence on the efficacy of different protective dressings in preventing NIV-related facial skin injury.
• Anticipated outcomes include data on skin injury prevention, device performance, patient-reported outcomes, and cost-effectiveness.

Conclusions:

• The study aims to generate comparative evidence on the effectiveness of various protective dressings for preventing NIV-related facial skin injuries.
• Findings are expected to inform evidence-based recommendations for clinical practice, improving patient care during NIV therapy.
• This research addresses a significant clinical challenge, potentially reducing complications and enhancing the success of NIV.