NCT06989385

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 325 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
OTHER	This is an observational study. Interventions are standard of care and include: High-flow nasal oxygen (HFNO) Non-invasive ventilation (NIV) Pnose monitoring	No experimental interventions are administered as part of the study.

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-05-25
• Last updated: 2026-01-22

Locations

1 site across 1 country: Italy