An observational study in ICU-acquired Weakness, Critical Illness Polyneuropathy and Critical Illness Myopathy, sponsored by First Affiliated Hospital of Wannan Medical College. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by First Affiliated Hospital of Wannan Medical College · Observational
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.
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 98 is close to the median of 100 across 53 observational studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →First Affiliated Hospital of Wannan Medical College is the lead sponsor of 37 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill adults on mechanical ventilation with an anticipated ICU stay greater than 7 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A cohort of adult patients newly admitted to the ICU who are receiving mechanical ventilation and are at risk for developing ICU-Acquired Weakness.
Diagnostic Test: Nerve Ultrasound with Shear Wave Elastography
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7 after ICU admission
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.
Time frame: Day 1 to Day 7 after ICU admission
Correlation between Nerve Elasticity and Disease Severity
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.
Time frame: Day 7
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jun 2027, 11 months later.
Of 26 observational studies under Polyneuropathies, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 93. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Wannan Medical College