Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT06911450
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of speckle-tracking ultrasound for pleural longitudinal strain measurement', 'timeFrame': 'At baseline (Day 1)', 'description': 'The feasibility is defined as achieving inter- and intra-observer consistency with an intraclass correlation coefficient (ICC) \\>0.75.\n\nMeasurement: ICC calculated from three repeated strain measurements by two independent operators.\n\nThreshold: ICC \\>0.75 indicates acceptable feasibility.'}, {'measure': 'Correlation between pleural longitudinal strain and driving pressure', 'timeFrame': 'During ventilator adjustment (Day 1)', 'description': "The strength of the linear relationship between pleural strain (continuous variable) and driving pressure (ΔP) measured by Pearson's correlation coefficient.\n\nThreshold: A Pearson's r \\>0.5 with a p-value \\<0.05 is predefined as a clinically significant correlation."}], 'secondaryOutcomes': [{'measure': 'Time required for ultrasound analysis', 'timeFrame': 'Immediately post-procedure (Day 1)', 'description': 'Total time (minutes) to acquire and analyze pleural strain data, reported as mean ± SD.'}, {'measure': 'Success rate of pleural strain measurement', 'timeFrame': 'At baseline (Day 1)', 'description': 'Percentage of patients with analyzable pleural strain data (e.g., clear speckle-tracking signal).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Speckle-Tracking Ultrasound', 'Pleural Longitudinal Strain', 'Mechanical Ventilation', 'Ventilator-Induced Lung Injury (VILI)', 'Lung Strain'], 'conditions': ['Ventilation, Mechanical', 'ARDS (Acute Respiratory Distress Syndrome)']}, 'descriptionModule': {'briefSummary': '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.\n\nWhy 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.\n\nBetter 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.\n\nWho 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.\n\nExcluded: People with recent chest surgery, broken ribs, nerve/muscle diseases, or pregnancy (to avoid risks and ensure accurate measurements).\n\nWhat will happen during the study?\n\nUltrasound scans:\n\nA 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.\n\nMeasurements:\n\nDoctors 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.\n\nHow will this help me or others? Direct benefit: You\'ll receive detailed monitoring of your lung function, which may help doctors personalize your care.\n\nFuture benefit: If successful, this technology could help doctors worldwide adjust ventilators more safely, reducing complications for ICU patients.\n\nIs 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.\n\nWho is conducting the study? Led by Dr. Xu Qiancheng and the ICU team at Yijishan Hospital, Wannan Medical College.\n\nExperts in ultrasound and critical care will ensure the study is safe and scientifically rigorous.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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:\n\nPhase 1 Cohort:\n\n25 non-ventilated patients (spontaneously breathing or on non-invasive oxygen therapy) with an APACHE II score \\>8.\n\nFocus: Technical validation of pleural strain measurement feasibility.\n\nPhase 2 Cohort:\n\n25 mechanically ventilated patients (invasive ventilation \\>24 hours) with an APACHE II score \\>8.\n\nFocus: Reproducibility of strain measurement under ventilator-induced motion artifacts.\n\nPhase 3 Subgroup:\n\nA subset of 25 patients who tolerate driving pressure adjustments (10, 15, 20 cmH₂O).\n\nFocus: Correlation between pleural strain and driving pressure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Phase 1: Feasibility Assessment in Non-Mechanically Ventilated Patients\n\nInclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \\>8.\n* Non-mechanically ventilated patients (either spontaneously breathing or receiving only non-invasive oxygen therapy).\n\nExclusion Criteria:\n\n* History of thoracic surgery or trauma.\n* Presence of pneumothorax or chest trauma (e.g., rib fractures, flail chest).\n* Pregnancy or age \\<18 years.\n* Refusal to participate by the patient or legal representative.\n* Poor ultrasound image quality (e.g., unclear pleural visualization).\n\nPhase 2: Feasibility Assessment in Mechanically Ventilated Patients\n\nInclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \\>8.\n* Receiving invasive mechanical ventilation for \\>24 hours.\n\nExclusion Criteria:\n\n* History of thoracic surgery or trauma.\n* Presence of pneumothorax or chest trauma (e.g., rib fractures, flail chest).\n* Pregnancy or age \\<18 years.\n* Requirement for high-frequency oscillatory ventilation.\n* Poor ultrasound image quality (e.g., pleural motion obscured by pleural effusion).\n\nPhase 3: Correlation Analysis of Strain and Driving Pressure in Mechanically Ventilated Patients\n\nInclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \\>8.\n* Receiving invasive mechanical ventilation for \\>24 hours.\n* Tolerance to stepwise driving pressure adjustments (10, 15, and 20 cmH₂O, maintained for 10 minutes each).\n\nExclusion Criteria:\n\n* History of thoracic surgery or trauma.\n* Presence of pneumothorax, chest trauma (e.g., rib fractures, flail chest), or significant patient-ventilator asynchrony.\n* Pregnancy or age \\<18 years.\n* Requirement for high-frequency oscillatory ventilation.\n* Hemodynamic instability (mean arterial pressure \\[MAP\\] \\<65 mmHg or requiring high-dose vasopressors).\n* Severe hypoxemia (PaO₂/FiO₂ \\<100 mmHg), precluding safe adjustment of driving pressure.\n* Poor ultrasound image quality (e.g., loss of pleural strain signal).'}, 'identificationModule': {'nctId': 'NCT06911450', 'briefTitle': 'Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wannan Medical College'}, 'officialTitle': 'Quantification of Pleural Longitudinal Strain by Speckle-Tracking Ultrasound: Feasibility and Associations With Driving Pressure in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': '2024174'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase one', 'description': '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'}, {'label': 'Phase two', 'description': "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)."}, {'label': 'Phase three', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '241000', 'city': 'Wuhu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengsheng Tao', 'role': 'CONTACT', 'email': 'taoshengsheng@yjsyy.com', 'phone': '86-18315329399'}], 'facility': 'The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}], 'centralContacts': [{'name': 'Qiancheng Xu', 'role': 'CONTACT', 'email': 'qianchengxu@wnmc.edu.cn', 'phone': '86-18297529106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wannan Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pleural Strain by Speckle-Tracking Ultrasound and Driving Pressure in Ventilated Patients', 'investigatorFullName': 'Qiancheng Xu', 'investigatorAffiliation': 'First Affiliated Hospital of Wannan Medical College'}}}}