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

NCT07069959 | Not Yet Recruiting

• 1 other identifier: RC25_0138
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intensive Care Unit Acquired Weakness; Muscle Weakness

Keywords

dynamometry; muscle weakness; intensive care; functional recovery; invasive mechanical ventilation; 3D ultrasound

Outcome Measures

Primary Outcomes (2)

• Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU.

  This study aims to describe the evolution of quadriceps muscle recovery in ICU patients under invasive mechanical ventilation, using manual dynamometry as a measurement tool. The recovery will be assessed periodically throughout the ICU stay to evaluate early muscle strength recovery.

  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.

  Change in the volume of the rectus femoris muscle measured by 3D ultrasound.

  3 months after ICU discharge

Secondary Outcomes (17)

• Estimate the average value of the FMQ

  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.

  From inclusion to 3 months post-ICU discharge

• Study the differences in muscle strength between right and left FMQ values on the same day

  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

  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

  From inclusion to ICU discharge, an average of 10 days

Study Arms (1)

Patients under invasive mechanical ventilation in the ICU

This group includes patients admitted to the Intensive Care Unit (ICU) at the CHU of Nantes, treated with invasive mechanical ventilation. The study aims to evaluate the early recovery of quadriceps muscle strength in these patients, using non-invasive, pain-free assessment methods. The cohort will consist of approximately 100 patients over one year, with data collected via the medical record and strength measurements performed by physical therapists.

Other: Early assessment of quadriceps muscle strength

Interventions

Early assessment of quadriceps muscle strength OTHER

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.

Patients under invasive mechanical ventilation in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults (aged \>18 years) admitted to the ICU and treated with invasive mechanical ventilation for at least 4 days. Participants must be conscious, cooperative, and have an MRC score ≥ 3/5 for "Leg Extension" on either side. Informed consent or no objection is required. Exclusion criteria include pregnancy, neurological disorders, lower limb injuries, or conditions preventing safe participation.

You may qualify if:

• Adults aged \> 18 years
• Hospitalized in an ICU
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire Atlantique, 44300, France

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Research and Innovation Departement of Nantes UH

CONTACT

+33253482810; bp-prom-regl@chu-nantes.fr

Jean REIGNIER, UH Practitioner

CONTACT

jean.reignier@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

FR (1)