- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Filippo Binda, MSc
- Phone Number: +39 02 5503 4954
- Email: filippo.binda@policlinico.mi.it
Study Contact Backup
- Name: Veronica Rossi, MSc
- Phone Number: +39 02 5503 4954
- Email: veronica.rossi@policlinico.mi.it
Study Locations
-
-
-
Milan, Italy, 20122
- Recruiting
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
-
Contact:
- Veronica Rossi, MSc
- Email: veronica.rossi@policlinico.mi.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between quadriceps strength and thickness
Time Frame: 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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps strength
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Veronica Rossi, MSc, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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