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

NCT06989385 | Recruiting

• 1 other identifier: UModenaReggio2025
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

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

Outcome Measures

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.

  30 days

Secondary Outcomes (1)

• Clinical impact

  From enrollment to 90 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

AOU Policlinico di Modena

Modena, 41125, Italy

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Roberto Tonelli, MD, PhD

CONTACT

+390594225934; rtonelli@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 25, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

IT (1)