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

University of Modena and Reggio Emilia

Status: Enrolling

Conditions: Acute Respiratory Failure

Treatments: Other: This is an observational study. Interventions are standard of care and include: High-flow nasal oxygen (HFNO) Non-invasive ventilation (NIV) Pnose monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06989385

UModenaReggio2025

Details and patient eligibility

About

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.

Enrollment: 325 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Hospitalization in the Respiratory Medicine Unit at AOU Policlinico di Modena
• Acute respiratory failure (hypoxemic and/or hypercapnic) with PaO₂/FiO₂ < 300 mmHg
• Undergoing treatment with HFNO or NIV

Exclusion criteria

• Immediate need for invasive ventilation upon admission
• Known neuromuscular disease
• Pregnancy
• Lack of informed consent