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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Early assessment of quadriceps muscle strength

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients under invasive mechanical ventilation in the ICU1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

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

Time frame
3 months after ICU discharge

Secondary outcomes

1

Estimate the average value of the FMQ

Measure the FMQ (Quadriceps Muscle Strength ) at multiple key time points to estimate recovery and muscle strength progression.

Time frame
From inclusion to 3 months post-ICU discharge
2

To study the correlation between FMQ values and other muscular and functional scores on the same day.

Correlate FMQ with other muscular and functional scores

Time frame
From inclusion to 3 months post-ICU discharge
3

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

Compare right and left side FMQ measurements to assess potential asymmetries.

Time frame
From inclusion to 3 months post-ICU discharge
4

Study the correlation between FMQ at inclusion and the time until extubation, when the patient was still intubated at inclusion

Investigate if FMQ at inclusion can predict extubation time in intubated patients.

Time frame
From inclusion to the day of extubation, an average of 7 days

Other outcomes

Sponsors and contacts

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