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Search / Trial NCT06669312

External Validation of the BREF Models

Launched by ISTITUTO CLINICO HUMANITAS · Oct 30, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Acute Respiratory Failure High Flow Oxygen Therapy Esophageal Pressure P Sili Breathing Effort

ClinConnect Summary

This clinical trial, called the BREF models study, is looking at how to better understand and measure the breathing efforts of patients who are experiencing acute respiratory failure (ARF). High-flow oxygen therapy is commonly used to help these patients, but sometimes their breathing can be too strong, which can cause further issues. The trial aims to see how well two newly developed models can predict these breathing efforts using simple information that can be easily gathered at the bedside, such as the patient’s respiratory rate and oxygen levels.

To participate in this study, you need to be an adult patient in the intensive care unit (ICU) who is receiving high-flow oxygen through a nasal device and has certain equipment available for monitoring. The researchers plan to enroll about 250 patients over the next two years. If you join, doctors will assess your breathing efforts using both the new models and their clinical judgment, and the actual pressures will be measured to see how accurate the models are. This study is important because it could help improve care for patients with respiratory distress by providing doctors with better tools to assess and manage their breathing efforts.

Gender

ALL

Eligibility 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.

About Istituto Clinico Humanitas

Istituto Clinico Humanitas is a leading clinical research organization based in Italy, dedicated to advancing medical science through innovative clinical trials and research initiatives. With a strong emphasis on patient-centered care and cutting-edge methodologies, the institute collaborates with various stakeholders in the healthcare sector to develop and evaluate new therapies and treatment protocols. Its multidisciplinary team of experts is committed to ensuring the highest standards of ethical practice and scientific rigor, contributing to significant advancements in medical knowledge and improved patient outcomes.

Locations

Rozzano, Milan, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported