Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696497
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2020-12-04
Brief Title:
Muscle Function and Muscle Ultrasound in ICU
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Evaluation of Muscle Function at Discharge From ICU Evaluation of the Correlation Between Manual Muscle Testing Dynamometric and Peripheral Ultrasound Parameters
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMIQUE
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 094 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 4860 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 patients 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 flexorsknee extensorsfoot lifters is correlated with manual MRC testing in intensive care unit ICU patients
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 094 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 4860 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 patients 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 flexorsknee extensorsfoot 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 patients 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 1515
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
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 patients 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 1515
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None