Muscle Function and Muscle Ultrasound in ICU

Not Applicable

Recruiting

• Conditions: Muscle Weakness
• Interventions: Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometric muscular assessment; Diagnostic Test: Manual muscular Assessment (MRC-SS)

• Registration Number: NCT04696497
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

The objective of intensive care therapists is to be able to detect as early as possible the muscle weakness acquired in intensive care, in order to implement curative strategies such as adapted nutrition and early rehabilitation. Various diagnostic tools are available for this purpose. To evaluate muscle mass, CT and MRI remain the gold standard but are difficult to implement in routine practice in ICU and are extremely expensive and can generate radiation for the patient.

Functional muscle evaluation is based on different voluntary tests which are not all able to predict muscle weakness acquired in ICU. In addition, some of the voluntary tests are expensive and require expert staff for practice and interpretation of results.

In addition, a muscle test such as MRC, although having an intraclass coefficient of 0.94, has little predictive value on clinical parameters such as mechanical ventilation duration and is not associated with mortality in the ward. However, it remains the test of choice to define a ICUAW with a threshold value of 48/60 points.

Dynamometry is a tool for measuring muscle strength. The patient is asked to perform a short and intense maximal muscular effort against manual or instrumental resistance. The limb segments must not move, it is an isometric effort. The most common measurement in intensive care units is the dynamometric grip force, called "handgrip".

In ICU, the patient may have touble with awareness, arousal or even comprehension, which will lead to biases in the evaluation of the motor force.

Ultrasound is a tool available in ICU and the muscle component can be assessed qualitatively or quantitatively without the patient's participation. Several studies have also demonstrated that muscle ultrasound is capable of reliably detecting pathological changes, particularly when repeated. Muscle ultrasound could thus help identify patients at higher risk of prolonged complications. Nevertheless, this technique lacks standardization and normative criteria (patient position, probe position, type and number of measurements, target muscle, etc.).

The main objective is to show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care unit (ICU) patients

Detailed Description

When the patient will be under invasive ventilatory support and coma, and will present the inclusion criteria, the investigator will perform ultrasound measurements of muscle thickness on four muscle groups:

* Shoulder Side muscular compartment

* Anterior Arm muscular compartment

* Anterior thigh muscular compartment

* Antero-lateral leg muscular compartment The ultrasound measurements will be made once a day each weekday, until the discharge from ICU.

Ultrasound measurements will be stopped if the patient's condition deteriorates and the ICU team chooses to limit active therapy.

If the patient condition get better, the investigator will perform the first volitional muscle function assessment, as soon as the patient Glasgow scale will score 15/15:

1. Medical Research Council sum score (MRC-ss)

2. Dynamometric strength assessment with the muscular groups used for the MRC-ss Then the volitional muscle assessment will be made once every 3 days, until patient discharges from ICU.

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Major patient > 18 years old
• Admission for more than 24 hours in the ICU ward
• Stay must be at least 72 hours

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Exclusion Criteria

• Person with a neuromuscular pathology
• Person presenting an osteoarticular contraindication to mobilization
• Amputee
• Person under guardianship or curatorship
• Person not affiliated to a social security system
• Pregnant Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscular Assessment	Ultrasound	All the patients will received the muscular assessments
Muscular Assessment	Dynamometric muscular assessment	All the patients will received the muscular assessments
Muscular Assessment	Manual muscular Assessment (MRC-SS)	All the patients will received the muscular assessments

Primary Outcome Measures

Name	Time	Method
Correlation coefficient between force/thickness ratio and MRC testing.	Day 28	To show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care medicine patients

Secondary Outcome Measures

Name	Time	Method
Change in force measured by dynamometry in patients with more than 2 evaluations	Day 28	Change in force measured by dynamometry in patients with more than 2 evaluations
Medical Research Council sum-score (MRC-ss)	Day 28	Following the same positions as for the dynamometer evaluation, the examiner will evaluate the 12 motor functions according to the following 60-point rating. With the maximum quote of 5 point representing normal strength and 0 point the total absence of any muscular contraction.
Modification in millimeters of ultrasound muscle thickness	Day 28	Modification in millimeters of ultrasound muscle thickness

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France