CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: This is an observational study. Interventions are standard of care and include: High-flow nasal oxygen (HFNO) Non-invasive ventilation (NIV) Pnose monitoring.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Rate of failure of non-invasive respiratory support [Time frame: 30 days]
Secondary outcome measures (1)
- Clinical impact [Time frame: From enrollment to 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- AOU Policlinico di Modena — Modena
Identifiers
NCT: NCT06989385 · UModenaReggio2025