Clinical Trial

The ROTAtional-USE of Interface STUDY

Study acronym: ROTA-USE
Recruiting
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-08-22; most recent amendment 2024-11-13.
Status change: Not Yet Recruiting → Recruiting 2022-12-22
Trial Details
NCT Number NCT05513508
Lead Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Conditions Pressure Ulcer, Noninvasive Positive Pressure Ventilation, Acute Hypercapnic Respiratory Failure
Enrollment 478 participants
Start Date 2022-12-08
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2024-11-14