Ultrasound eye on the diaphragm may forecast breathing-tube success
NCT ID NCT07733102
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This study tests whether a new ultrasound-based index, called the Regional Diaphragmatic Synchrony Index (RDSI), can predict if patients on ventilators will succeed when their breathing tube is removed. Researchers will measure diaphragm movement and thickness in 110 adults during a spontaneous breathing trial. The goal is to see if this index outperforms standard weaning tests in predicting who can breathe independently without needing the tube back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the index proves accurate, it could help doctors decide when to safely remove breathing tubes, reducing failed extubations and complications.
- What could go wrong
- This is an early observational study, not a treatment trial. The index may not outperform existing methods or may be difficult to apply in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adult patients (aged 18 years and older) who have received invasive mechanical ventilation for at least 24 hours and are clinically ready for their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode. Eligible participants must be hemodynamically stable (MAP ≥ 65 mmHg with or without low-dose vasopressors) and have adequate oxygenation (FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O) to safely undergo the SBT. Patients with known diaphragm paralysis, inadequate ultrasound windows, severe agitation, or those who are pregnant will be excluded. Written informed consent will be obtained from the patient or their legally authorized representative prior to enrollment.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: Age ≥ 18 years. * Mechanical Ventilation Duration: Receiving invasive mechanical ventilation for ≥ 24 hours. * Weaning Readiness: The attending physician has determined that the patient meets the criteria for weaning assessment and plans to conduct a Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode. * Hemodynamic Stability: Hemodynamically stable prior to the SBT, defined as a mean arterial pressure (MAP) ≥ 65 mmHg, or requiring only low-dose vasopressor support. * Oxygenation Criteria: Oxygenation status permits an SBT, typically defined as FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O, or meeting the standard weaning assessment criteria of the participating institution. Exclusion Criteria: * Known or highly suspected phrenic nerve injury, or unilateral/bilateral diaphragmatic paralysis. * Neuromuscular diseases causing severely restricted spontaneous breathing capacity, as judged by the investigator to be unsuitable for RDSI analysis. * Recent chest or upper abdominal surgery, open trauma, skin infection, or extensive dressing coverage that prevents obtaining a reliable diaphragm ultrasound window. * Significant agitation or severe patient-ventilator asynchrony that prevents the acquisition of continuous and stable respiratory cycles. * Undrained pneumothorax, or conditions deemed unsuitable for ultrasound examination as judged by the attending physician. * Pregnant patients. * The patient or their legally authorized representative refuses to participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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