Psoas Muscle Index (PMI) as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-99
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elderly patients (≥ 65 years old)

Able to take consent

Listed for minimally invasive cardiac surgery

Elective and urgent procedures included

Disqualifiers

Full median sternotomy approach

Emergency procedures

Unable to take consent

Unable to undergo MRI

Trial population

Cardiac surgery patients undergoing heart valve surgery via a minimally invasive approach

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lower Abdomen MRI

    Other intervention

    The patients will undergo a lower abdomen MRI to assess the size of the psoas muscle and derive the PMI

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Postoperative Intensive care unit (ITU) stay

Total number of hours spent in ITU after the primary (indexed) cardiac operation

Time frame
perioperatively/periprocedurally
2

Postoperative overall length of stay

Total number of days spent in hospital after the primary (indexed) cardiac operation

Time frame
perioperatively/periprocedurally
3

Mobilization time

Time to mobilization after the primary (indexed) cardiac operation defined as standing up or sitting down for at least 3 consecutive hours

Time frame
perioperatively/periprocedurally

Secondary outcomes

1

Postoperative mortality

In hospital mortality after the primary (indexed) cardiac operation

Time frame
perioperatively/periprocedurally
2

Long term mortality

Mortality at the latest follow up after the primary (indexed) cardiac operation

Time frame
at 1 year
3

Postoperative Complications

Any surgical related postoperative complication related to the primary (indexed) cardiac operation

Time frame
at 30 days

Other outcomes

Sponsors and contacts

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