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Search / Trial NCT07120438

Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients

Launched by GADJAH MADA UNIVERSITY · Aug 6, 2025

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Diaphragmatic Ultrasound Rapid Shallow Breathing Index Diaphragm Thickening Fraction Diaphragm Excursion Weaning Prediction Icu Weaning Failure

ClinConnect Summary

This clinical trial is studying the best way to predict if patients in the ICU who have been on a breathing machine (ventilator) for more than two days can be successfully taken off it. The researchers want to compare two methods: using an ultrasound to look at the diaphragm (the main muscle used for breathing) and measuring something called the Rapid Shallow Breathing Index (RSBI), which is a simple way to assess breathing patterns. The goal is to find out which method better predicts if a patient can breathe well enough on their own after being taken off the ventilator.

Adults who have been on a ventilator for more than 48 hours and are stable enough to try breathing without the machine may be eligible to join. Before removing the breathing tube, participants will have an ultrasound exam of their diaphragm and a breathing test to measure the RSBI. The study will then see how these test results match up with whether the patient successfully stays off the ventilator. This research could help doctors decide the safest and most effective way to know when patients are ready to breathe on their own, which is very important for recovery in the ICU.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients who have been on mechanical ventilation for more than 48 hours
  • 2. Adult patients aged ≥18 years
  • 3. Patients who meet the criteria for hemodynamic stability for weaning
  • 4. Patients or their families have provided written informed consent
  • 5. Patients with FiO₂ \< 50%, PEEP level \< 5 cm H₂O, respiratory rate \< 30 breaths per minute, PaO₂/FiO₂ \> 200, and GCS \> 13
  • 6. Patients who have successfully completed the Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)
  • Exclusion Criteria:
  • 1. Patients with neuromuscular disorders, anatomical abnormalities of the diaphragm, or diaphragmatic palsy
  • 2. Patients with a history of severe thoracic trauma affecting diaphragm function on one or both sides
  • 3. Pregnancy

About Gadjah Mada University

Gadjah Mada University, a prestigious institution located in Yogyakarta, Indonesia, is recognized for its commitment to advancing research and innovation in various fields, including health sciences. As a clinical trial sponsor, the university leverages its extensive academic expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at enhancing medical knowledge and improving patient outcomes. With a focus on ethical standards and scientific integrity, Gadjah Mada University collaborates with healthcare professionals and researchers to ensure that its clinical trials contribute valuable insights to the medical community and support the development of effective treatments.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported