CompletedNot Applicable

The Use of Musculoskeletal Ultrasound for the Detection of ICU-Acquired Weakness

Nepal114 participantsStarted 2021-10-01

Plain-language summary

Intensive Care Unit-Acquired Weakness (ICU-AW) is a clinical entity frequently encountered in critically ill patients that have both short term and long-term implications. The current gold standard of diagnosis is by assessment of manual muscle strength, using the 6-grade Medical Research Council (MRC) sum score. However, not all Intensive Care Unit (ICU) admitted patients are conscious or cooperative enough to use MRC sum score for the diagnosis of ICU-AW. Ultrasound imaging of muscles has emerged as a valid and reliable tool for providing qualitative and quantitative details about muscle disease and has been suggested as an alternative to assess ICU-AW in critically ill patients in whom the MRC cannot be assessed. This study will be a prospective observational study to evaluate the relationship between the trend of changes in muscle thickness, echogenicity and fasciculations during the first 7 days of ICU stay as measured by ultrasound and ICU-AW among critically ill patients. The study will be performed in the ICU of TU Teaching Hospital, Kathmandu, Nepal for 1 year. All newly admitted adult patients ≥ 16 years of age, expected to stay in ICU / critical care areas for at least 7 days, barring the exclusion criteria, will be included in the study and evaluated for MRC sum score and skeletal muscle thickness, echogenicity and fasciculations using ultrasound on day 1, day 4 and day 7. The measurements will then be statistically analyzed to see if there is any relationship between trend of changes in muscle thickness, echogenicity and fasciculations and ICU-AW

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All newly admitted patients (shifted to ICU within 48 h of hospital admission) * Age ≥ 16 years * Expected to stay in ICU or critical care areas for 7 days Exclusion Criteria: * Patients with an admission diagnosis of a neuromuscular disorder * Patients with an admission diagnosis of stroke * Patients with an admission diagnosis of cardiac arrest * Patients with an admission diagnosis of traumatic brain injury * Patients with an admission diagnosis of spinal injury * Patients with an admission diagnosis of intracerebral infection or space-occupying lesion * Patients transferred from ICU of another hospital * Patients with a poor pre-hospital functional status (modified Rankin \>3) * Patients in whom no arms or no legs were available for muscle strength testing or ultrasound

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the relationship between trend of changes in muscle thickness, echogenicity and fasciculations and ICU-AW among critically ill patients

Timeframe: 7 DAYS

Trial details

NCT IDNCT05048953

SponsorB.P. Koirala Institute of Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-01

View on ClinicalTrials.gov More ICU Acquired Weakness trials