DYNAMIQUE: Muscle Function and Muscle Ultrasound in ICU

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Recruiting
CT.gov ID
NCT04696497
Collaborator
(none)
59
1
1
24
2.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound
  • Diagnostic Test: Dynamometric muscular assessment
  • Diagnostic Test: Manual muscular Assessment (MRC-SS)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Muscle Function at Discharge From ICU: Evaluation of the Correlation Between Manual Muscle Testing, Dynamometric and Peripheral Ultrasound Parameters
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Feb 14, 2023
Anticipated Study Completion Date :
Feb 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Muscular Assessment

All the patients will received the muscular assessments

Diagnostic Test: Ultrasound
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

Diagnostic Test: Dynamometric muscular assessment
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.

Diagnostic Test: Manual muscular Assessment (MRC-SS)
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Modification in millimeters of ultrasound muscle thickness [Day 28]

    Modification in millimeters of ultrasound muscle thickness

  2. 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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Major patient > 18 years old

  • Admission for more than 24 hours in the ICU ward

  • Stay must be at least 72 hours

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR d'Orléans Orléans France 45067

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Guillaume FOSSAT, CHR d'Orléans

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT04696497
Other Study ID Numbers:
  • CHRO-2020-02
First Posted:
Jan 6, 2021
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022