Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Wannan Medical College
About this trial
What is this study about? This research aims to test a new ultrasound technology called "speckle tracking" to measure how much the lining of your lungs (pleura) stretches during breathing, especially if you're on a breathing machine (ventilator). Doctors want to see if this technology can help them adjust ventilator settings more safely, reducing the risk of lung damage.
Why is this important? Lung protection: Patients on ventilators, especially those with severe lung problems (like ARDS or pneumonia), need careful settings. Too much pressure from the ventilator can harm the lungs.
Better monitoring: Current tools can't easily measure lung stretching at the bedside. This ultrasound method might offer a simple, painless way to check lung health in real time.
Who can join? Included: Adults (18+ years) in the ICU with serious illness (assessed by a standard score called APACHE II \>8), whether on a ventilator or not.
Excluded: People with recent chest surgery, broken ribs, nerve/muscle diseases, or pregnancy (to avoid risks and ensure accurate measurements).
What will happen during the study?
Ultrasound scans:
A small probe will be placed gently on your chest for 5-10 minutes. The machine will record videos of your lung movements during breathing. This is painless and uses no radiation.
Measurements:
Doctors will repeat the scan twice (10 minutes apart) to check consistency. For ventilator patients, scans will be done at different pressure settings to see how lung stretching changes.
How will this help me or others? Direct benefit: You'll receive detailed monitoring of your lung function, which may help doctors personalize your care.
Future benefit: If successful, this technology could help doctors worldwide adjust ventilators more safely, reducing complications for ICU patients.
Is my information safe? All data (scans, medical records) will be anonymized and stored securely. Participation is voluntary, and you can withdraw anytime without affecting your treatment.
Who is conducting the study? Led by Dr. Xu Qiancheng and the ICU team at Yijishan Hospital, Wannan Medical College.
Experts in ultrasound and critical care will ensure the study is safe and scientifically rigorous.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) admitted to the ICU with an APACHE II score >8.
Non-mechanically ventilated patients (either spontaneously breathing or receiving only non-invasive oxygen therapy).
Disqualifiers
History of thoracic surgery or trauma.
Presence of pneumothorax or chest trauma (e.g., rib fractures, flail chest).
Pregnancy or age <18 years.
Refusal to participate by the patient or legal representative.
Trial population
This prospective observational study enrolls critically ill patients in the intensive care unit (ICU) to evaluate the feasibility and clinical relevance of speckle-tracking ultrasound for pleural strain measurement. The study population is divided into three sequential phases: Phase 1 Cohort: 25 non-ventilated patients (spontaneously breathing or on non-invasive oxygen therapy) with an APACHE II score \>8. Focus: Technical validation of pleural strain measurement feasibility. Phase 2 Cohort: 25 mechanically ventilated patients (invasive ventilation \>24 hours) with an APACHE II score \>8. Focus: Reproducibility of strain measurement under ventilator-induced motion artifacts. Phase 3 Subgroup: A subset of 25 patients who tolerate driving pressure adjustments (10, 15, 20 cmH₂O). Focus: Correlation between pleural strain and driving pressure.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 3 trial groupsGroup A: Phase one
Group B: Phase two
Group C: Phase three
Trial outcomes
Primary outcomes
1
Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement
The feasibility is defined as achieving inter- and intra-observer consistency with an intraclass correlation coefficient (ICC) \>0.75. Measurement: ICC calculated from three repeated strain measurements by two independent operators. Threshold: ICC \>0.75 indicates acceptable feasibility.
Time frame
At baseline (Day 1)2
Correlation between pleural longitudinal strain and driving pressure
The strength of the linear relationship between pleural strain (continuous variable) and driving pressure (ΔP) measured by Pearson's correlation coefficient. Threshold: A Pearson's r \>0.5 with a p-value \<0.05 is predefined as a clinically significant correlation.
Time frame
During ventilator adjustment (Day 1)Secondary outcomes
1
Time required for ultrasound analysis
Total time (minutes) to acquire and analyze pleural strain data, reported as mean ± SD.
Time frame
Immediately post-procedure (Day 1)2
Success rate of pleural strain measurement
Percentage of patients with analyzable pleural strain data (e.g., clear speckle-tracking signal).
Time frame
At baseline (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov