NCT06289244

Correlation Between Muscle Strength and Thickness in Critically Ill Patients

Correlation Between Muscle Strength and Thickness in Critically Ill Patients: an Observational Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV? * How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV?

Detailed description

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.

Conditions

• Critical Illness
• Muscle Weakness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound	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.
DIAGNOSTIC_TEST	Muscle strength measurement	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.

Timeline

• Start date: 2023-06-06
• Primary completion: 2025-03-30
• Completion: 2025-06-30
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

1 site across 1 country: Italy