Correlation Between Muscle Strength and Thickness in Critically Ill Patients

NCT06289244 | Recruiting

• 1 other identifier: 6597
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

Critical Illness; Muscle Weakness

Keywords

Intensive Care Units; Respiration, Artificial; Limb Muscle Assessment; Diaphragm thickness; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Intensive Care Unit (ICU) who are expected to need mechanical ventilation for at least 48 hours following ARDS.

You may qualify if:

• Age ≥ 18 years;
• Intubated patients on mechanical ventilation presumably for 48 hours;
• Informed consent

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 34583135 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.

  PMID: 27310484 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Muscle Weakness; Respiratory Aspiration; Respiratory Distress Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Veronica Rossi, MSc

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: March 1, 2024
• Study Start: June 6, 2023
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)