Muscle Function and Muscle Ultrasound in ICU

NCT04696497 | Terminated

• 1 other identifier: CHRO-2020-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Muscle Weakness

Keywords

Intensive care unit; Dynamometric; Ultrasound; Medical Research Council sum score; Ultrasonography; Muscle Strength; Critical Care

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between force/thickness ratio and MRC testing.

  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

  Day 28

Secondary Outcomes (3)

• Modification in millimeters of ultrasound muscle thickness

  Day 28

• Change in force measured by dynamometry in patients with more than 2 evaluations

  Day 28

• Medical Research Council sum-score (MRC-ss)

  Day 28

Study Arms (1)

Muscular Assessment

OTHER

All the patients will received the muscular assessments

Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometric muscular assessment; Diagnostic Test: Manual muscular Assessment (MRC-SS)

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound measurements of muscle thickness, using a linear probe (high frequency) on four muscle groups: * Shoulder Side muscular compartment * Anterior Arm muscular compartment * Anterior thigh muscular compartment * Antero-lateral leg muscular compartment

Muscular Assessment

Dynamometric muscular assessment DIAGNOSTIC_TEST

The principle of electronic dynamometry is to measure an isometric force. To carry out these measurements, the examiner will stand on the side who has to be tested by exerting a pressure diametrically opposite to the patient's movement, thus preventing him/her from carrying out the movement. The patient will perform 3 tests for each movement, the best value will be collected by the examiner. The reference position is : Patient elbowed to the body bent at 90°, with trunk inclination at 30° in the resuscitation bed, lower limbs flat.

Muscular Assessment

Manual muscular Assessment (MRC-SS) DIAGNOSTIC_TEST

Following the same positions as for the dynamometer, 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

Muscular Assessment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (5)

• Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

  PMID: 24758618 BACKGROUND

• Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.

  PMID: 26242743 BACKGROUND

• Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.

  PMID: 16763220 BACKGROUND

• Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.

  PMID: 20089197 BACKGROUND

• Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

  PMID: 12594312 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Guillaume FOSSAT

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 6, 2021
• Study Start: December 17, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

FR (1)