Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care… (NCT07069959) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation
France100 participantsStarted 2025-08-01
Plain-language summary
Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.
Who can participate
Age range
18 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:
* Adults aged \> 18 years
* Hospitalized in an ICU
* Treated with invasive mechanical ventilation (MV) for at least 4 days during their stay (may be extubated at the time of inclusion)
* Conscious and cooperative patients: ability to respond appropriately to the following commands: open and close eyes, look at me, nod your head, stick out your tongue, raise your eyebrows when I count to five
* MRC score ≥ 3/5 for the "Leg Extension" function on either the left or right side
* Informed consent obtained (no opposition)
Exclusion Criteria:
* Pregnant or breastfeeding women
* Fracture or amputation of a lower limb
* Acute or chronic brain or spinal cord injury responsible for hemiplegia or paraplegia
* Unstable spinal injury
* Neurodegenerative or chronic neurological disease
* Guillain-Barré Syndrome
* Myasthenia Gravis
* Acute deep vein thrombosis of the lower limbs treated within the last 48 hours
* Pre-existing motor deficit in a lower limb before the ICU stay, of any cause
* Incarcerated or legally protected individuals (guardianship, curatorship)
* Individuals without social protection
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.
1My loved one is on a ventilator in the ICU — could they be at risk for ICU-acquired muscle weakness, and is that something their care team is already monitoring?
2This study is tracking quadriceps strength using manual dynamometry and 3D ultrasound, which seem like non-invasive assessments — could you explain whether participating would add any physical burden or risk on top of what they're already going through in the ICU?
3Since this trial is listed as 'not yet recruiting,' how would we find out when it opens, and is there a similar study already underway where my family member might benefit from this kind of muscle monitoring now?
4The trial focuses on describing how muscle recovery evolves over time rather than testing a treatment — so would joining this study affect or change the standard care my family member receives while on the ventilator?
5Given the concern about ICU-acquired weakness, are there existing rehabilitation strategies or early physiotherapy approaches you would recommend for my family member regardless of whether they participate in this study?
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
1
Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU.
Timeframe: 3 months
2
Description of the evolution of the recovery of the rectus femoris muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation.