RecruitingNCT06989385

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


Sponsor

University of Modena and Reggio Emilia

Enrollment

325 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

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

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Interventions

OTHERThis 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.


Locations(1)

AOU Policlinico di Modena

Modena, Italy

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NCT06989385


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