ARDS (Acute Respiratory Distress Syndrome), Ventilation, Mechanical
Conditions
Keywords
Speckle-Tracking Ultrasound, Pleural Longitudinal Strain, Mechanical Ventilation, Ventilator-Induced Lung Injury (VILI), Lung Strain
Brief summary
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.
Interventions
None listed
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Phase 1: Feasibility Assessment in Non-Mechanically Ventilated Patients Inclusion Criteria: * 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).
Exclusion criteria
* 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. * Poor ultrasound image quality (e.g., unclear pleural visualization). Phase 2: Feasibility Assessment in Mechanically Ventilated Patients Inclusion Criteria: * Adult patients (≥18 years) admitted to the ICU with an APACHE II score \>8. * Receiving invasive mechanical ventilation for \>24 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement | At baseline (Day 1) | 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. |
| Correlation between pleural longitudinal strain and driving pressure | During ventilator adjustment (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for ultrasound analysis | Immediately post-procedure (Day 1) | Total time (minutes) to acquire and analyze pleural strain data, reported as mean ± SD. |
| Success rate of pleural strain measurement | At baseline (Day 1) | Percentage of patients with analyzable pleural strain data (e.g., clear speckle-tracking signal). |
Countries
China
Contacts
Primary ContactQiancheng Xu
Outcome results
None listed