Correlation Between Muscle Strength and Thickness in Critically Ill Patients

Recruiting

• Conditions: Critical Illness; Muscle Weakness

• Registration Number: NCT06289244
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.

Study Timeline

• Study Start: 2023-06-06
• Status Verified: 2024-02
• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between quadriceps strength and thickness	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)	Degree of correlation between quadriceps strength, measured via handheld dynamometer (strength in Newton), and thickness, measured using ultrasound (thickness in cm).

Secondary Outcome Measures

Name	Time	Method
Quadriceps strength	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)	Mean difference of quadriceps strength along ICU stay period
Diaphragm thickness	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)	Mean difference of diaphragm thickness along ICU stay period
Diaphragm strength	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)	Mean difference of diaphragm thickness along ICU stay period
Time 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)	Mean difference of number of days required to reach the sitting position
Quadriceps thickness	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)	Mean difference of quadriceps thickness along ICU stay period

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy