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Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.
The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.
The primary inquiries this study seeks to address are:
The methodology for measuring the thickness of the diaphragm and quadriceps involves the use of bedside ultrasound. In terms of diaphragmatic assessment, to ensure consistency over multiple timepoints, the areas of the lower limbs evaluated (Quadriceps thickness, Qthick and Cross section area, CSA) will be marked on the skin using a dermatographic pen during the peripheral assessments.
Muscle strength in the limbs will be assessed utilizing the Medical Research Council (MRC) Score, specifically in patients who are awake and cooperative (RASS 0 +/- 1). Additionally, a dynamometer will be employed for the precise measurement of quadriceps strength, serving as the gold standard.
The timeline for data collection during the observational period is structured as follows:
T1: 48-72 hours from the start of invasive MV after intubation T2: At the initial trial in pressure support mode. T3: Immediately prior to extubation. T4: Before discharge from the Intensive Care Unit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | The thickness of the diaphragm and quadriceps will be assessed using bedside ultrasound, utilizing a 13-6 MHz cm linear probe. The measurement of the right hemidiaphragm's end-expiratory thickness will be conducted via diaphragm ultrasound. For accurate positioning, the ultrasound probe will be placed along the right anterior axillary line, specifically between the ninth and tenth intercostal spaces, in a sagittal oblique orientation. To enhance measurement consistency, the probe's position on the skin will be marked. To ascertain accuracy, the operator will conduct each measurement three times, and the mean of these three values will be used for analysis. Similarly, for diaphragmatic assessment and peripheral assessments (Qthick and CSA) of the lower limbs, the examination areas will be demarcated on the skin with a dermatographic pen, ensuring measurement reproducibility over different timepoints. | ||
| Muscle strength measurement | Diagnostic Test | The assessment of limb muscle strength in this study will be conducted using the Medical Research Council (MRC) Score. For a more precise evaluation of quadriceps strength, a dynamometer will be employed. Furthermore, the study will incorporate an invasive method for gauging inspiratory muscle strength, utilizing the negative inspiratory force (NIF) metric. Post-extubation, the maximum inspiratory pressure (MIP) will be determined using an electronic manometer. Three separate MIP measurements will be executed, and the highest reading among these will be recorded as the definitive measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between quadriceps strength and thickness | Degree of correlation between quadriceps strength, measured via handheld dynamometer (strength in Newton), and thickness, measured using ultrasound (thickness in cm). | The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps strength | Mean difference of quadriceps strength along ICU stay period | The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the Intensive Care Unit (ICU) who are expected to need mechanical ventilation for at least 48 hours following ARDS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica Rossi, MSc | Contact | +39 02 5503 4954 | veronica.rossi@policlinico.mi.it | |
| Filippo Binda, MSc | Contact | +39 02 5503 4954 | filippo.binda@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Veronica Rossi, MSc | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34583135 | Background | Umbrello M, Guglielmetti L, Formenti P, Antonucci E, Cereghini S, Filardo C, Montanari G, Muttini S. Qualitative and quantitative muscle ultrasound changes in patients with COVID-19-related ARDS. Nutrition. 2021 Nov-Dec;91-92:111449. doi: 10.1016/j.nut.2021.111449. Epub 2021 Aug 15. | |
| 27310484 | Background | Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018908 | Muscle Weakness |
| D053120 | Respiratory Aspiration |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Quadriceps thickness |
Mean difference of quadriceps thickness along ICU stay period |
| The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
| Diaphragm thickness | Mean difference of diaphragm thickness along ICU stay period | The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
| Diaphragm strength | Mean difference of diaphragm thickness along ICU stay period | The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
| Time to reach the sitting position | Mean difference of number of days required to reach the sitting position | The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months) |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |