A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF. (ROTA-USE)

NCT05513508 NA RECRUITING

In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).

Details

Lead sponsor	Azienda Ospedaliero Universitaria Maggiore della Carita
Phase	NA
Status	RECRUITING
Enrolment	478
Start date	2022-12-08
Completion	2028-09

Conditions

• Pressure Ulcer
• Noninvasive Positive Pressure Ventilation
• Acute Hypercapnic Respiratory Failure

Interventions

• Protocolized rotational use of interfaces
• Standard of care

Primary outcomes

• Proportion of patients who develop new pressure sores — At 36 hours from randomization
  To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with AHRF treated continuously i.e., for more than 24 hours, with NIV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).

Countries

Italy