Ventilation, MechanicalNCT06911450
Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations
An observational study of Ventilation, Mechanical and ARDS (Acute Respiratory Distress Syndrome), run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilation, Mechanical, ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 31 May 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- Adult patients (≥18 years) admitted to the ICU with an APACHE II score >8.
- Receiving invasive mechanical ventilation for >24 hours.
- 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).
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000
Shengsheng Tao, 86-18315329399, taoshengsheng@yjsyy.com
About this study
Official title: Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients
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.
Read more
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.
- Keywords
- Speckle-Tracking Ultrasound, Pleural Longitudinal Strain, Mechanical Ventilation, Ventilator-Induced Lung Injury (VILI), Lung Strain
- Medical subject headings
- Respiratory Aspiration, Acute Lung Injury, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase one | This phase aims to evaluate the feasibility and consistency of speckle-tracking technology for measuring pleural longitudinal strain. A cohort of 25 critically ill non-ventilated patients (APACHE II score >8) was enrolled. A single operator acquired 10-second pleural videos at the upper blue point position using a GE Vivid iq ultrasound system (GE Healthcare, USA) with a superficial probe. Two independent operators subsequently analyzed the lung ultrasound (LUS) clips offline using GE EchoPAC software (version 203, GE Healthcare, USA) to derive the maximum pleural longitudinal strain. Each measurement was performed three times, and the average value was recorded. The same measurements were repeated one week later. Inter- and intra-observer consistency was assessed using the intraclass correlation coefficient (ICC), where values range from 0 (poor agreement) to 1 (perfect agreement). An ICC >0.75 was predefined as indicating good consistency, thereby validating the feasibility of apply | |
| Phase two | This phase evaluates the feasibility and reproducibility of speckle-tracking technology in mechanically ventilated patients. Twenty-five eligible mechanically ventilated patients were included. Ultrasound acquisition and pleural strain measurement protocols mirrored those in Phase 1. To assess intra-operator reproducibility, each operator performed duplicate measurements at 10-minute intervals. Operators were blinded to each other's results, and each parameter was measured three times with the average value recorded. Inter- and intra-observer consistency was analyzed using ICC, with thresholds identical to Phase 1 (ICC >0.75 indicating acceptable reproducibility). | |
| Phase three | This phase investigates the correlation between pleural longitudinal strain and driving pressure (ΔP) in 25 mechanically ventilated patients. Speckle-tracking ultrasound was used to measure pleural strain at three distinct driving pressure levels (10, 15, and 20 cmH₂O). The Pearson correlation coefficient was employed to quantify the linear relationship between pleural strain (continuous variable) and driving pressure. Statistical significance was defined as a two-tailed p-value <0.05. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement
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.
Measured: At baseline (Day 1)
Correlation between pleural longitudinal strain and driving pressure
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.
Measured: During ventilator adjustment (Day 1)
Secondary outcomes (2)
Time required for ultrasound analysis
Total time (minutes) to acquire and analyze pleural strain data, reported as mean ± SD.
Measured: Immediately post-procedure (Day 1)
Success rate of pleural strain measurement
Percentage of patients with analyzable pleural strain data (e.g., clear speckle-tracking signal).
Measured: At baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start5 Dec 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911450
- Sponsor's protocol ID
- 2024174
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06911450
- Acronym / sponsor ID
- 2024174
- Keywords
- Speckle-Tracking Ultrasound, Pleural Longitudinal Strain, Mechanical Ventilation, Ventilator-Induced Lung Injury (VILI), Lung Strain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase one | – | –This phase aims to evaluate the feasibility and consistency of speckle-tracking technology for measuring pleural longitudinal strain. A cohort of 25 critically ill non-ventilated patients (APACHE II score >8) was enrolled. A single operator acquired 10-second pleural videos at the upper blue point position using a GE Vivid iq ultrasound system (GE Healthcare, USA) with a superficial probe. Two independent operators subsequently analyzed the lung ultrasound (LUS) clips offline using GE EchoPAC software (version 203, GE Healthcare, USA) to derive the maximum pleural longitudinal strain. Each measurement was performed three times, and the average value was recorded. The same measurements were repeated one week later. Inter- and intra-observer consistency was assessed using the intraclass correlation coefficient (ICC), where values range from 0 (poor agreement) to 1 (perfect agreement). An ICC >0.75 was predefined as indicating good consistency, thereby validating the feasibility of apply |
| Phase two | – | –This phase evaluates the feasibility and reproducibility of speckle-tracking technology in mechanically ventilated patients. Twenty-five eligible mechanically ventilated patients were included. Ultrasound acquisition and pleural strain measurement protocols mirrored those in Phase 1. To assess intra-operator reproducibility, each operator performed duplicate measurements at 10-minute intervals. Operators were blinded to each other's results, and each parameter was measured three times with the average value recorded. Inter- and intra-observer consistency was analyzed using ICC, with thresholds identical to Phase 1 (ICC >0.75 indicating acceptable reproducibility). |
| Phase three | – | –This phase investigates the correlation between pleural longitudinal strain and driving pressure (ΔP) in 25 mechanically ventilated patients. Speckle-tracking ultrasound was used to measure pleural strain at three distinct driving pressure levels (10, 15, and 20 cmH₂O). The Pearson correlation coefficient was employed to quantify the linear relationship between pleural strain (continuous variable) and driving pressure. Statistical significance was defined as a two-tailed p-value <0.05. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
- Adult patients (≥18 years) admitted to the ICU with an APACHE II score >8.
- Receiving invasive mechanical ventilation for >24 hours.
- Adult patients (≥18 years) admitted to the ICU with an APACHE II score >8.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Time required for ultrasound analysis
Time frame: Immediately post-procedure (Day 1)
Success rate of pleural strain measurement
Time frame: At baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes
Related trials for Ventilation, Mechanical
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Recruiting
Titration of PS Guided by FI : A Pilot Study
Mechanical Ventilation
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation, Mechanical and ARDS (Acute Respiratory Distress Syndrome), run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement (time frame: At baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.