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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06989385

Acronym

CORALINE

Enrollment

325

Registered

2025-05-25

Start date

2024-11-01

Completion date

2030-01-01

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure, High flow nasal cannula, Non-invasive ventilation, Inspiratory effort

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.

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of failure of non-invasive respiratory support	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

Measure	Time frame	Description
Clinical impact	From enrollment to 90 days	Mortality

Countries

Italy

Contacts

CONTACTRoberto Tonelli, MD, PhD

rtonelli@unimore.it+390594225934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026