NCT06989385 CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
| NCT ID | NCT06989385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Modena and Reggio Emilia |
| Condition | Acute Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 325 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 325 participants in total. It began in 2024-11-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06989385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06989385 currently recruiting?
Yes, NCT06989385 is actively recruiting participants. Contact the research team at rtonelli@unimore.it for enrollment information.
Where is the NCT06989385 trial being conducted?
This trial is being conducted at Modena, Italy.
Who is sponsoring the NCT06989385 clinical trial?
NCT06989385 is sponsored by University of Modena and Reggio Emilia. The trial plans to enroll 325 participants.