CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure

This observational study aims to evaluate the relationship between clinical and physiological variables and the failure of non-invasive respiratory support (NIRS), including high-flow nasal oxygen (HFNO) and non-invasive ventilation (NIV), in patients with acute respiratory failure (ARF), both hypoxemic and/or hypercapnic. The study includes both retrospective and prospective components. Retrospective data will be collected from patient charts, while prospective data will be collected at defined time points during clinical care. The primary outcome is NIRS failure, defined as the need for orotracheal intubation. Secondary outcomes include in-hospital and 90-day mortality, ICU and hospital length of stay, and duration of non-invasive and invasive support.

NCT Number	NCT06989385
Lead Sponsor	University of Modena and Reggio Emilia
Conditions	Acute Respiratory Failure
Enrollment	325 participants
Start Date	2024-11-01
Primary Completion	2028-01-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-22