Rotational Use of Interfaces Versus Standard Care for Patients Treated With Noninvasive Positive Pressure Ventilation for Acute Hypercapnic Respiratory Failure

What this Trial Is About

Researchers are evaluating whether switching between different types of masks during noninvasive positive pressure ventilation (NPPV) is more effective and cost-efficient than standard care in reducing pressure sores in patients with acute hypercapnic respiratory failure (AHRF). This study focuses on patients treated continuously for more than 24 hours with NPPV to avoid invasive ventilation or to assist early extubation and weaning. The trial aims to compare the incidence and severity of pressure sores, patient comfort, and treatment adherence between the two approaches. Participants are randomly assigned to either a protocolized rotational use of interfaces group, where masks are changed every 6 hours alternating between two types commonly used in each center, or to a standard care group, where the mask type and changes are based on patient comfort and standard practices. Masks used include oro-nasal, total face, or hybrid types, with protective dressings applied to the nasal bridge when using oro-nasal masks. Both groups receive NPPV treatment until no longer needed, following established clinical guidelines, with skin inspections every 12 hours by trained assessors. During the study, patients will be monitored for new pressure sores at multiple time points up to 96 hours from randomization, discomfort levels related to the mask, treatment interruptions, and other clinical variables like nutritional status and hospital stay length. Data on pressure sore stage, location, and number will be collected, alongside cost-effectiveness analysis of the rotational mask protocol. Safety is overseen with interim analysis planned, and treatment adherence and skin care protocols are carefully documented throughout the hospital stay.

The ROTAtional-USE of Interface STUDY