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

NCT ID: NCT07069959

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intensive Care Unit Acquired Weakness Muscle Weakness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Early assessment of quadriceps muscle strength

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire Atlantique, France

Site Status

Countries

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France

Central Contacts

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Research and Innovation Departement of Nantes UH

Role: CONTACT

+33253482810

Jean REIGNIER, UH Practitioner

Role: CONTACT

Facility Contacts

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Jean REIGNIER, UH Practitioner

Role: primary

+33240087365

Other Identifiers

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RC25_0138

Identifier Type: -

Identifier Source: org_study_id

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