Measuring lung stretching with ultrasound in ventilated patients
Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients
This study is testing a new ultrasound method to see how much the lining of the lungs stretches during breathing in ICU patients on ventilators, to help doctors adjust the machines safely and reduce lung injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Wuhu, Anhui) |
| Trial ID | NCT06911450 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate a new ultrasound technology called 'speckle tracking' to assess how much the pleura, the lining of the lungs, stretches during breathing, particularly in patients on mechanical ventilation. The goal is to determine if this technology can help clinicians adjust ventilator settings more safely, thereby reducing the risk of ventilator-induced lung injury. The study will include adult patients in the ICU with serious illnesses, using a standard scoring system to assess their condition. Both mechanically ventilated and non-ventilated patients will be considered for participation, while those with recent chest trauma or surgery will be excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older admitted to the ICU with an APACHE II score greater than 8.
Not a fit: Patients with recent chest surgery, broken ribs, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer ventilator management and improved lung protection for critically ill patients.
How similar studies have performed: While this approach is innovative, similar studies using ultrasound for lung assessment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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. 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. * Requirement for high-frequency oscillatory ventilation. * Poor ultrasound image quality (e.g., pleural motion obscured by pleural effusion). Phase 3: Correlation Analysis of Strain and Driving Pressure 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. * Tolerance to stepwise driving pressure adjustments (10, 15, and 20 cmH₂O, maintained for 10 minutes each). Exclusion Criteria: * History of thoracic surgery or trauma. * Presence of pneumothorax, chest trauma (e.g., rib fractures, flail chest), or significant patient-ventilator asynchrony. * Pregnancy or age \<18 years. * Requirement for high-frequency oscillatory ventilation. * Hemodynamic instability (mean arterial pressure \[MAP\] \<65 mmHg or requiring high-dose vasopressors). * Severe hypoxemia (PaO₂/FiO₂ \<100 mmHg), precluding safe adjustment of driving pressure. * Poor ultrasound image quality (e.g., loss of pleural strain signal).
Where this trial is running
Wuhu, Anhui
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) — Wuhu, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Qiancheng Xu
- Email: qianchengxu@wnmc.edu.cn
- Phone: 86-18297529106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.