Correlation of clinical and breathing measures with failure of non-invasive respiratory support in acute respiratory failure
Official title: CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
Run by University of Modena and Reggio Emilia · NCT06989385 · Data updated 2026-11-12
This project will try to see if routine clinical signs and breathing measurements can predict when high-flow oxygen or non-invasive ventilation won't prevent the need for a breathing tube in adults with acute respiratory failure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 325 (estimated) |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 1 site (Modena) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2030 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT06989385 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) hospitalized in the Respiratory Medicine Unit at AOU Policlinico di Modena with acute hypoxemic and/or hypercapnic respiratory failure (PaO2/FiO2 < 300) who are being treated with HFNO or NIV and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients who need immediate invasive ventilation on arrival, have known neuromuscular disease, are pregnant, or receive care outside the enrolling center are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study combining retrospective chart review with prospective physiological data collection in hospitalized adults with acute respiratory failure treated with high-flow nasal oxygen or non-invasive ventilation. Clinical variables and bedside respiratory measurements, including inspiratory effort monitoring, will be recorded at defined time points during routine care. The primary outcome is failure of non-invasive respiratory support, defined as need for orotracheal intubation; secondary outcomes include in-hospital and 90-day mortality, ICU and hospital length of stay, and durations of non-invasive and invasive support. Data will be collected at AOU Policlinico di Modena and analyzed to identify which variables are associated with non-invasive support failure.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients on HFNO or NIV who are likely to need intubation sooner, allowing earlier escalation of care and potentially improving outcomes.
How similar studies have gone: Previous observational research has identified clinical and physiologic predictors of non-invasive support failure, though the addition of nasal pressure (Pnose) inspiratory-effort monitoring in routine care is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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AOU Policlinico di Modena
Modena, Italy Recruiting
Study contacts
- Study coordinator: Roberto Tonelli, MD, PhD
- Email: rtonelli@unimore.it
- Phone: +390594225934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.