Correlation Between Muscle Strength and Thickness in Critically Ill Patients (NCT06289244) | Clinical Trial Compass
UnknownNot Applicable
Correlation Between Muscle Strength and Thickness in Critically Ill Patients
Italy50 participantsStarted 2023-06-06
Plain-language 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?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between quadriceps strength and thickness
Timeframe: 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)
Trial details
NCT IDNCT06289244
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico