Muscle Function and Muscle Ultrasound in ICU (DYNAMIQUE)
Primary Purpose
Muscle Weakness
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound
Dynamometric muscular assessment
Manual muscular Assessment (MRC-SS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscle Weakness focused on measuring Intensive care unit, Dynamometric, Ultrasound, Medical Research Council sum score, Ultrasonography, Muscle Strength, Critical Care
Eligibility Criteria
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
Sites / Locations
- CHR d'OrléansRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Muscular Assessment
Arm Description
All the patients will received the muscular assessments
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Modification in millimeters of ultrasound muscle thickness
Modification in millimeters of ultrasound muscle thickness
Change in force measured by dynamometry in patients with more than 2 evaluations
Change in force measured by dynamometry in patients with more than 2 evaluations
Medical Research Council sum-score (MRC-ss)
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.
Full Information
NCT ID
NCT04696497
First Posted
December 4, 2020
Last Updated
March 10, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT04696497
Brief Title
Muscle Function and Muscle Ultrasound in ICU
Acronym
DYNAMIQUE
Official Title
Evaluation of Muscle Function at Discharge From ICU: Evaluation of the Correlation Between Manual Muscle Testing, Dynamometric and Peripheral Ultrasound Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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:
Medical Research Council sum score (MRC-ss)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Intensive care unit, Dynamometric, Ultrasound, Medical Research Council sum score, Ultrasonography, Muscle Strength, Critical Care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscular Assessment
Arm Type
Other
Arm Description
All the patients will received the muscular assessments
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamometric muscular assessment
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Manual muscular Assessment (MRC-SS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation coefficient between force/thickness ratio and MRC testing.
Description
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
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Modification in millimeters of ultrasound muscle thickness
Description
Modification in millimeters of ultrasound muscle thickness
Time Frame
Day 28
Title
Change in force measured by dynamometry in patients with more than 2 evaluations
Description
Change in force measured by dynamometry in patients with more than 2 evaluations
Time Frame
Day 28
Title
Medical Research Council sum-score (MRC-ss)
Description
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.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DESPUJOLS
Phone
+33238744071
Email
aurelie.despujols@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie POUGOUE TOUKO
Phone
+33238744086
Email
elodie.pougoue-touko@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume FOSSAT
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume FOSSAT
Email
guillaume.fossat@chr-orleans.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
24758618
Citation
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.
Results Reference
background
PubMed Identifier
26242743
Citation
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.
Results Reference
background
PubMed Identifier
16763220
Citation
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.
Results Reference
background
PubMed Identifier
20089197
Citation
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.
Results Reference
background
PubMed Identifier
12594312
Citation
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.
Results Reference
background
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Muscle Function and Muscle Ultrasound in ICU
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