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

Recruiting now

Conditions studied: Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT06989385

Run by

University of Modena and Reggio Emilia

People needed

325

Starts

2024-11-01

Expected to finish

2030-01-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• AOU Policlinico di Modena — Modena, Italy (enrolling)

Full record on ClinicalTrials.gov

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