Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571643
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-16
Brief Title:
Psoas Muscle Index PMI as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Psoas Muscle Index PMI as a Predictor of Mobilisation and Postoperative Length of Stay After Minimally Invasive Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PsoMICS
Brief Summary:
Sarcopenia or muscle loss and function is a component of the frailty syndrome In this sense frailty is becoming an important risk factor in predicting outcomes after major surgery and is defined as a geriatric syndrome of decreased reserve and resiliency to stressors that have been associated with adverse health outcomes in older adults Despite its potentially relevant role in predicting postoperative recovery frailty is rarely evaluated before surgery and this is partially due to the low reliability of the most used frailty scores Therefore improvement in the frailty evaluation would be beneficial during the preoperative assessment of major surgeries Sarcopenia or the decline of skeletal muscle tissue with age is one of the most important causes of functional decline and loss of independence in older adults and low muscle mass is a core component of frailty that has the advantage of being objectively quantifiable regardless of mobility disability or illness acuity Psoas Muscle PM mass is an important parameter for evaluating muscle mass and has been previously correlated to frailty with a negative impact on the postoperative outcomes after major surgery and Psoas Muscle mass Index PMI is an easily available parameter for evaluating muscle mass and has already been demonstrated to be effective in predicting outcomes in different clinical settings PMI has also been shown to be an effective predictor of outcomes in cardiac surgery although there are no studies specifically focusing on minimally invasive cardiac surgery With this study the investigators aim to investigate the relevance of PMI as a predictor of postoperative mobilisation hospital length of stay and clinical recovery after major cardiac surgery conducted via a minimally invasive approach
Detailed Description:
This is a prospective controlled observational single-centre study of patients undergoing minimally invasive heart valve surgery at the department of minimally invasive cardiac surgery of the IRCCS Galeazzi SantAmbrogio Hospital in Milan Italy
The primary endpoint is to evaluate the role of psoas muscle index PMI in predicting length of stay and early mobility after heart valve surgery via a minimally invasive approach
25 consecutive participants patients undergoing minimally invasive cardiac surgery will be assessed with a lower abdomen MRI before the surgery to evaluate the diameter of the psoas muscle and therefore assess the Psoas Muscle Index PMI Frailty will be evaluated using the PRISMA-7 questionnaire
PMI value will be correlated with the main outcomes via regression methods and adjusted for covariates
The participants will be consented to the study before the cardiac surgery operation indexed procedure Surgeries will include aortic mitral and tricuspid valve operations conducted either via a mini-thoracotomy or a mini-sternotomy approach and every patient will receive routine preoperative operative and postoperative cardiac surgery care In addition to standard cardiac surgery clinical variables the investigators will collect data on
Total intubation hours
Total Intensive Treatment Unit ITU length of stay
Total postoperative length of hospital stay
Time between end of surgery and first mobilisation see below
The primary endpoint is to evaluate the role of psoas muscle index PMI in predicting length of stay and early mobility after heart valve surgery via a minimally invasive approach
25 consecutive participants patients undergoing minimally invasive cardiac surgery will be assessed with a lower abdomen MRI before the surgery to evaluate the diameter of the psoas muscle and therefore assess the Psoas Muscle Index PMI Frailty will be evaluated using the PRISMA-7 questionnaire
PMI value will be correlated with the main outcomes via regression methods and adjusted for covariates
The participants will be consented to the study before the cardiac surgery operation indexed procedure Surgeries will include aortic mitral and tricuspid valve operations conducted either via a mini-thoracotomy or a mini-sternotomy approach and every patient will receive routine preoperative operative and postoperative cardiac surgery care In addition to standard cardiac surgery clinical variables the investigators will collect data on
Total intubation hours
Total Intensive Treatment Unit ITU length of stay
Total postoperative length of hospital stay
Time between end of surgery and first mobilisation see below
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None