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

NCT ID: NCT06989385

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2030-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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This 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role lead

Responsible Party

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Roberto Tonelli

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOU Policlinico di Modena

Modena, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto Tonelli, MD, PhD

Role: CONTACT

+390594225934

Facility Contacts

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Roberto Tonelli, MD

Role: primary

0039 0594225934

Other Identifiers

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UModenaReggio2025

Identifier Type: -

Identifier Source: org_study_id

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