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NCT Number: NCT06911450

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

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.

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Key information

Conditions

Ventilation, Mechanical ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhu, Anhui, 241000, China

Location status: Recruiting

Location contact

Shengsheng Tao

CONTACT

[email protected]

86-18315329399

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement

    Time frame: 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.

  2. Correlation between pleural longitudinal strain and driving pressure

    Time frame: 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 outcomes

  1. Time required for ultrasound analysis

    Time frame: Immediately post-procedure (Day 1)

    Total time (minutes) to acquire and analyze pleural strain data, reported as mean ± SD.

  2. Success rate of pleural strain measurement

    Time frame: At baseline (Day 1)

    Percentage of patients with analyzable pleural strain data (e.g., clear speckle-tracking signal).

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Xu

CONTACT

[email protected]

86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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