Clinical trial NCT06911450: Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations
Official title: Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilation, Mechanical
ARDS (Acute Respiratory Distress Syndrome)
Keywords: Speckle-Tracking Ultrasound
Pleural Longitudinal Strain
Mechanical Ventilation
Ventilator-Induced Lung Injury (VILI)
Lung Strain
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility 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).

Primary outcomes:
measure: Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement
timeFrame: At baseline (Day 1)
measure: Correlation between pleural longitudinal strain and driving pressure
timeFrame: During ventilator adjustment (Day 1)
Secondary outcomes:
measure: Time required for ultrasound analysis
timeFrame: Immediately post-procedure (Day 1)
measure: Success rate of pleural strain measurement
timeFrame: At baseline (Day 1)
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
state: Anhui
Study officials:
References: