Parasternal Intercostal Ultrasound vs RSBI for Weaning Prediction (NCT07144878) | Clinical Trial Compass
CompletedNot Applicable
Parasternal Intercostal Ultrasound vs RSBI for Weaning Prediction
Egypt50 participantsStarted 2023-10-03
Plain-language summary
Mechanical ventilation is essential in the management of critically ill patients, but deciding the proper time to wean and extubate remains a significant challenge. Extubation failure is associated with poor outcomes, including prolonged intensive care unit stay, higher risk of complications, and increased mortality. The rapid shallow breathing index (RSBI) is widely used to predict weaning readiness, but its predictive accuracy is limited. Recently, ultrasound evaluation of respiratory muscles, particularly the parasternal intercostal muscle, has been proposed as a promising bedside tool to assess respiratory effort and load.
This comparative clinical trial was conducted on adult intensive care unit patients at Benha University Hospital who were mechanically ventilated for ≤24 hours and ready for a spontaneous breathing trial. Each patient underwent both rapid shallow breathing index (RSBI) measurement and parasternal intercostal muscle ultrasound prior to the trial. Patients were classified into successful or failed weaning groups based on trial outcome. The study compared the diagnostic accuracy of both methods and aimed to determine whether ultrasound assessment of the parasternal intercostal muscle offers a more reliable predictor of weaning success than rapid shallow breathing index (RSBI).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Both sexes
* Patients invasively mechanically ventilated for up to 24 hours and ready to undergo a spontaneous breathing trial
* Patients considered ready for spontaneous breathing trial if all of the following were met:
* Alert and afebrile
* Fraction of inspired oxygen less than 50 percent
* Positive end-expiratory pressure less than or equal to 8 centimeters of water
* Ratio of arterial oxygen partial pressure to fraction of inspired oxygen greater than 200
* Arterial blood pH between 7.35 and 7.45
* Respiratory rate less than or equal to 35 breaths per minute
* Hemodynamically stable without vasopressor support
Exclusion Criteria:
* Age younger than 18 years
* Pregnancy
* Surgical dressings near or over the sternum that prevent ultrasound examination
* Body mass index less than 18.5 kilograms per square meter (underweight)
* Body mass index greater than or equal to 40 kilograms per square meter (morbid obesity)
* Primary neuromuscular diseases
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.
What they're measuring
1
Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation
Timeframe: Baseline, immediately prior to the spontaneous breathing trial