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Study identifier: NCT06669312 Synced from ClinicalTrials.gov · July 28, 2026
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External Validation of the BREF Models

Condition: Acute Respiratory Failure · Oxygen Inhalation Therapy · Respiratory Distress  ·  Sponsor: Istituto Clinico Humanitas

PhaseN/A
Planned participants250
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Introduction High-flow oxygen therapy is increasingly used to treat acute respiratory failure (ARF). It can reduce intubation rates without increasing mortality. Moreover, it is better tolerated than other non-invasive respiratory support therapies. However, patients with ARF often make strong breathing efforts, which may cause several harm. They can fatigue the respiratory muscles. They can increase whole-body oxygen consumption and carbon dioxide production. They can cause pulmonary edema. They might also injure the diaphragm and the lungs. For all these reasons, strong breathing efforts should be recognized and treated. During spontaneous breathing, inspiratory muscle contractions produce parallel deflections of the pleural and esophageal pressure (ΔPes), which reflect the magnitude of the effort. Unlike changes in pleural pressure, ΔPes can be easily measured at the bedside using a catheter similar to a typical nasogastric tube. In healthy subjects, ΔPes is only a few cmH2O during quiet breathing but \>10-15 cmH2O during vigorous exercise or carbon dioxide inhalation. In patients with ARF, the upper limit for a "safe" ΔPes is unknown. Nonetheless, according to experts, breathing efforts with a ΔPes \>10-15 cmH2O are probably too strong to be tolerated for a long time. However, esophageal manometry is not widely available. Estimating breathing efforts without it is complex, especially in non-intubated patients. Doctors mostly rely on their gestalt or overall impression. …

This description comes directly from the study's public registry record.

Talk to the study team

Alessandro Protti, MD  ·  +39 02 82244135  ·  alessandro.protti@hunimed.eu

Always discuss trial participation with your own doctor first.

Locations (1)

IRCCS Humanitas Research HospitalRozzano, Milan, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06669312