Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation

Official title

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation: A Monocentric and Prospective Study.

Overview

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.

Interventions

• Other Early assessment of quadriceps muscle strength
  Patients will undergo non-invasive assessment of quadriceps muscle strength using manual dynamometry and 3D ultrasound. These assessments will be conducted regularly during their ICU stay to evaluate early recovery. The intervention is part of routine patient care and does not involve additional treatments or procedures.

Primary outcome measures

• Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU. [Time frame: 3 months]
• Description of the evolution of the recovery of the rectus femoris muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation. [Time frame: 3 months after ICU discharge]

Secondary outcome measures (12)

• Estimate the average value of the FMQ [Time frame: From inclusion to 3 months post-ICU discharge]
• To study the correlation between FMQ values and other muscular and functional scores on the same day. [Time frame: From inclusion to 3 months post-ICU discharge]
• Study the differences in muscle strength between right and left FMQ values on the same day [Time frame: From inclusion to 3 months post-ICU discharge]
• Study the correlation between FMQ at inclusion and the time until extubation, when the patient was still intubated at inclusion [Time frame: From inclusion to the day of extubation, an average of 7 days]
• Study the correlation between FMQ at inclusion and the ability to achieve verticalization for patients who could stand before ICU discharge [Time frame: From inclusion to ICU discharge, an average of 10 days]
• Study the correlation between FMQ at inclusion and the ability to take the first steps for patients who were able to walk before ICU discharge [Time frame: From inclusion to ICU discharge, an average of 10 days]
• Search for an association (survival model) between FMQ (Nm/kg) measured on the day of inclusion and the time (in days) between inclusion and the first steps taken successfully. [Time frame: 3 months post-ICU discharge]
• Examine how FMQ and VFMQ correlate with strength and functional measures at follow-up, and how physical activity impacts recovery. [Time frame: 3 months post-ICU discharge]
• Description of the recovery of the anterior tibial muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation. [Time frame: 3 months after ICU discharge]
• Correlation between changes in rectus femoris volume and functional recovery. [Time frame: 3 months after ICU discharge]
• Correlation between changes in anterior tibial muscle volume and functional recovery. [Time frame: 3 months after ICU discharge]
• Correlation between changes in rectus femoris volume and muscle strength assessment tools. [Time frame: 3 months after ICU discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

France · 1 center

• Nantes University Hospital — Nantes

Identifiers

NCT: NCT07069959 · RC25_0138

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗