About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Immediate need for invasive ventilation upon admission
Known neuromuscular disease
Pregnancy
Lack of informed consent
Trial population
Patients admitted to the Respiratory Disease Unit of the University of Modena and Reggio Emilia
Trial design
Cohort
Prospective
Treatments tested in this trial
This is an observational study. Interventions are standard of care and include: High-flow nasal oxygen (HFNO) Non-invasive ventilation (NIV) Pnose monitoring
Other interventionNo experimental interventions are administered as part of the study.
Treatment groups
Trial outcomes
Primary outcomes
Rate of failure of non-invasive respiratory support
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
Mortality
Sponsors and contacts
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