Measuring lung stretching with ultrasound in ventilated patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.