CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 325
- Primary Endpoint
- Rate of failure of non-invasive respiratory support
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Rate of failure of non-invasive respiratory support
Time Frame: 30 days
Number of patients experiencing NIRS failure (defined as escalation to another NIRS modality, need for orotracheal intubation, or death) over the total number of patients.
Secondary Outcomes
- Clinical impact(From enrollment to 90 days)
Investigators
Roberto Tonelli
Assistant Professor
University of Modena and Reggio Emilia