Correlation Between Muscle Strength and Thickness in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289244
• Other study ID #: 6597
• Status: Recruiting
• Start date: June 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Veronica Rossi, MSc
• Phone: +39 02 5503 4954
• Email: veronica.rossi[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years;

• Intubated patients on mechanical ventilation presumably for 48 hours;

• Informed consent

Exclusion Criteria:

• Contraindication (absolute or relative) to assessment: acute bleeding, multiple fractures or trauma, spinal instability;

• Hemodynamic instability during assessment;

• ICU admission due to thoracic surgery, including lung transplant patients;

• History of preexisting neuromuscular diseases;

• History of preexisting functional impairment;

• Pheripheral Neural disease;

• Cervical spine injury;

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)