Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventil… (NCT07120438) | Clinical Trial Compass
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Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients
55 participantsStarted 2025-08
Plain-language summary
The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours.
The main question it aims to answer is:
Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \[DE\] and Diaphragm Thickening Fraction \[DTF\]) or RSBI, in patients ventilated \>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta?
Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes.
Secondary objectives include:
1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.
2. Evaluating the correlation between DE values and successful weaning.
3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.
4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.
5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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Inclusion criteria
. Patients who have been on mechanical ventilation for more than 48 hours
. Adult patients aged ≥18 years
. Patients who meet the criteria for hemodynamic stability for weaning
. Patients or their families have provided written informed consent
. Patients with FiO₂ \< 50%, PEEP level \< 5 cm H₂O, respiratory rate \< 30 breaths per minute, PaO₂/FiO₂ \> 200, and GCS \> 13
. Patients who have successfully completed the Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.