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This study aims to determine whether shear wave elastography (SWE), a non-invasive ultrasound technique that measures nerve stiffness, can help detect ICU-acquired weakness (ICU-AW) early in critically ill patients. Adults receiving mechanical ventilation in the ICU will undergo ultrasound examinations of the median and tibial nerves on Days 1, 4, and 7. The study will evaluate whether early changes in nerve elasticity can predict ICU-AW, which is usually diagnosed later using a muscle strength score that requires patient cooperation.
Intensive Care Unit-Acquired Weakness (ICU-AW) is a common and severe complication in critically ill patients, associated with poor long-term outcomes. The current gold standard for diagnosis, the Medical Research Council (MRC) score, requires patient cooperation and is often delayed.
Shear Wave Elastography (SWE) is an advanced ultrasound technique that quantitatively measures tissue stiffness. Pathophysiological changes in ICU-AW, such as axonal degeneration and edema in nerves, are expected to alter their biomechanical properties (elasticity). This study posits that these changes may be detectable early using SWE, preceding overt clinical weakness.
This study will prospectively enroll adult patients admitted to the ICU who are expected to require prolonged mechanical ventilation. Participants will undergo serial ultrasound examinations of the median and tibial nerves on days 1, 4, and 7 of their ICU stay. The examinations will include SWE to measure nerve elasticity (stiffness) and conventional B-mode ultrasound to measure nerve cross-sectional area (CSA).
On day 7, all consenting and cooperative patients will be assessed for ICU-AW using the MRC score. The primary objective is to determine the diagnostic accuracy of early nerve SWE measurements for predicting the diagnosis of ICU-AW on Day 7. Secondary objectives include describing the dynamic changes in nerve elasticity and size over the first week, and exploring the correlation between these ultrasound parameters and clinical severity scores and patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU Patients on Mechanical Ventilation | A cohort of adult patients newly admitted to the ICU who are receiving mechanical ventilation and are at risk for developing ICU-Acquired Weakness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Ultrasound with Shear Wave Elastography | Diagnostic Test | Patients will undergo non-invasive ultrasound examinations of the median nerve and tibial nerve at the bedside on days 1, 4, and 7. The examination includes Shear Wave Elastography (SWE) to quantify nerve stiffness (elasticity) and B-mode imaging to measure nerve cross-sectional area (CSA). This is a purely observational procedure and does not alter patient management. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Nerve SWE on Day 1 for Predicting ICU-AW on Day 7 | Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission: Day 1 - to predict ICU-AW diagnosed on Day 7 Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other) ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points. | Day 1 and Day 7 after ICU admission |
| Diagnostic Accuracy of Nerve SWE on Day 4 for Predicting ICU-AW on Day 7 | Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission: Day 4 - to predict ICU-AW diagnosed on Day 7 Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other) ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points. | Day 4 and Day 7 after ICU admission |
| Diagnostic Accuracy of Nerve SWE on Day 7 for Diagnosing ICU-AW on Day 7 | Area Under the Receiver Operating Characteristic Curve (AUC) for the mean elasticity value (measured in kilopascals, kPa) of the median and tibial nerves, assessed separately at three time points after ICU admission: Day 7 - for concurrent diagnosis of ICU-AW (elastography and MRC assessed independently, blinded to each other) ICU-Acquired Weakness (ICU-AW) is defined as a Medical Research Council (MRC) sum score of less than 48 points. | Day 7 after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nerve Elasticity | Absolute and relative change in the shear wave elastography (SWE) value (in kPa) of the median and tibial nerves from baseline (Day 1) to Day 7. | Day 1 to Day 7 after ICU admission |
| Correlation between Nerve Elasticity and Disease Severity |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill adults on mechanical ventilation with an anticipated ICU stay greater than 7 days.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qiancheng xu, PhD | Contact | +86-18297529106 | xu19871011@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Wuhu | Anhui | 241001 | China |
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Spearman's correlation coefficient will be calculated to assess the relationship between the baseline (Day 7) nerve SWE values and the baseline Sequential Organ Failure Assessment (SOFA) score. |
| Day 7 |
| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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