Validating the BREF models for estimating breathing effort in ICU patients on high-flow nasal oxygen.
Official title: External Validation of the BREF Models for Estimating the Breathing Effort During High-flow Oxygen Therapy
Run by Istituto Clinico Humanitas · NCT06669312 · Data updated 2026-11-12
This project tests whether BREF models can accurately estimate breathing effort from esophageal pressure recordings in adults in the ICU receiving high-flow nasal oxygen.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milan) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT06669312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) in the ICU who are receiving high-flow nasal oxygen and have an esophageal balloon placed as part of routine care, without chronic lung disease or cardiogenic pulmonary edema and within 96 hours of admission.
✕Probably not a fit
Patients with chronic lung disease, cardiogenic pulmonary edema, those not instrumented with an esophageal balloon, or those admitted more than 96 hours earlier are unlikely to be eligible or to benefit from this validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, single-center effort will externally validate the BREF predictive models by comparing model outputs to measured esophageal pressure swings (ΔPes) in adult ICU patients treated with high-flow nasal cannula. Patients who are already instrumented with an esophageal balloon as part of local clinical care will have ΔPes recordings collected and matched to the models' predictions. Enrollment excludes patients with chronic lung disease or cardiogenic pulmonary edema and requires inclusion within 96 hours of admission; no interventional therapy is applied by the protocol. The analysis will quantify model accuracy and generalizability to a routine ICU population.
Why it matters
Potential benefit: If validated, the models could give clinicians a simple bedside tool to detect strong breathing efforts earlier and help prevent respiratory or diaphragmatic injury.
How similar studies have gone: Prior research shows esophageal pressure swings correlate with inspiratory effort and HFNC can reduce intubation rates, but external validation of the BREF predictive models in routine ICU populations is limited, making this work relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * adult (≥18 years of age) patients in the ICU * treated with high-flow oxygen delivered via nasal cannula * equipped with an esophageal balloon as per local clinical practice. Exclusion criteria: * history of chronic lung disease * cardiogenic pulmonary edema * \>96 hours from admission to the participating unit.
Where it's running
-
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy Recruiting
Study contacts
- Study coordinator: Alessandro Protti, MD
- Email: alessandro.protti@hunimed.eu
- Phone: +39 02 82244135
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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.