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RecruitingNCT06989385CORALINEUpdated Jan 22, 2026

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

An observational study in Acute Respiratory Failure, sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by University of Modena and Reggio Emilia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
325
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • Acute respiratory failure
  • High flow nasal cannula
  • Non-invasive ventilation
  • Inspiratory effort
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the Respiratory Disease Unit of the University of Modena and Reggio Emilia

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

Exclusion Criteria:

  • Immediate need for invasive ventilation upon admission
  • Known neuromuscular disease
  • Pregnancy
  • Lack of informed consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
325 participants (estimated)
Patient registry
No

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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

  1. Clinical impact

    Mortality

    Time frame: From enrollment to 90 days

06

Study locations

1 of 1 sites recruiting
  • AOU Policlinico di Modena
    Modena, 41125, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06989385
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Roberto Tonelli (Assistant Professor, University of Modena and Reggio Emilia) — Principal investigator
First posted
May 25, 2025
Start date
Nov 1, 2024
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Jan 22, 2026

Study contacts

Roberto Tonelli, MD, PhD
Contact
rtonelli@unimore.it
+390594225934

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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