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NCT Number: NCT06989385

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

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.

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This is an observational study. Interventions are standard of care and include: High-flow nasal oxygen (HFNO) Non-invasive ventilation (NIV) Pnose monitoring

Other

No experimental interventions are administered as part of the study.

Primary outcomes

  1. 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

  1. Clinical impact

    Time frame: From enrollment to 90 days

    Mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Tonelli, MD, PhD

CONTACT

[email protected]

+390594225934

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: CORALINE

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
May 25, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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