Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06911450

Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2025-04-04

75

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older admitted to the ICU with an APACHE II score greater than 8
  • Non-mechanically ventilated patients who are spontaneously breathing or on non-invasive oxygen therapy
  • Patients receiving invasive mechanical ventilation for more than 24 hours
  • Patients who can tolerate stepwise ventilator driving pressure adjustments at 10, 15, and 20 cmH2O for 10 minutes each (for phase 3)
Not Eligible

You will not qualify if you...

  • History of thoracic surgery or chest trauma such as rib fractures or flail chest
  • Presence of pneumothorax or chest trauma
  • Pregnancy or age less than 18 years
  • Refusal to participate by the patient or legal representative
  • Poor ultrasound image quality that prevents clear pleural visualization
  • Requirement for high-frequency oscillatory ventilation
  • Significant patient-ventilator asynchrony
  • Hemodynamic instability with mean arterial pressure less than 65 mmHg or need for high-dose vasopressors
  • Severe hypoxemia with PaO2/FiO2 less than 100 mmHg

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China, 241000

Actively Recruiting

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Research Team

Q

Qiancheng Xu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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