Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289244
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-04
Brief Title:
Correlation Between Muscle Strength and Thickness in Critically Ill Patients
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Correlation Between Muscle Strength and Thickness in Critically Ill Patients an Observational Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None