About this trial
This study investigates whether the Sarcopenia Index (SI = serum creatinine/cystatin C × 100), a simple biomarker derived from routine blood tests, can predict weaning success in critically ill patients undergoing invasive mechanical ventilation in the intensive care unit. SI will be measured at the spontaneous breathing trial (SBT), and its predictive value will be compared with diaphragm ultrasound parameters - diaphragm thickening fraction (DTF) and diaphragm excursion (DE) - as well as other established weaning parameters. The goal is to determine whether SI can serve as an accessible, low-cost alternative or complement to ultrasound-based assessment in predicting successful liberation from mechanical ventilation, and to establish a population-specific SI cutoff value for this setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older
Received invasive mechanical ventilation for at least 24 hours
Weaned from invasive mechanical ventilation via a spontaneous breathing trial (SBT) after meeting weaning criteria
Patients on at least 24-hour invasive mechanical ventilator support receiving antibiotherapy, in whom serum cystatin C was measured
Disqualifiers
Pregnancy
Neuromuscular disease
High cervical spinal cord injury
Terminal-stage malignancy
Trial population
Adult patients admitted to the intensive care unit at Kocaeli City Hospital who require invasive mechanical ventilation for at least 24 hours and undergo a spontaneous breathing trial for weaning.
Trial design
Cohort
Prospective
Treatments tested in this trial
sarcopenia index
Other interventionA calculated biomarker derived from routinely measured serum creatinine and serum cystatin C values \[(creatinine/cystatin C) × 100\], obtained at the time of the spontaneous breathing trial.
diaphragma ultrasound
Other interventionNon-invasive, point-of-care bedside ultrasonography of the diaphragm performed at the time of the spontaneous breathing trial using a linear high-frequency probe (3-14 MHz) at the 8th-10th intercostal space between the anterior and mid-axillary lines. Diaphragm excursion (DE) is measured with a curvilinear probe (1.3-5.7 MHz) in M-mode. End-expiratory and end-inspiratory diaphragm thickness are measured, and the diaphragm thickening fraction (DTF) is calculated as \[(inspiratory thickness - expiratory thickness) / expiratory thickness\] × 100. This is a diagnostic imaging assessment, not a therapeutic intervention, and involves no ionizing radiation or additional risk to the patient.
parameters of mechanical ventilation (MV)
Other interventionStandard bedside weaning parameters recorded by the investigator at the time of the spontaneous breathing trial: Rapid Shallow Breathing Index (RSBI, respiratory rate/tidal volume ratio), Negative Inspiratory Force (NIF/PImax, maximal inspiratory pressure), and Airway Occlusion Pressure at 0.1 seconds (P0.1). These are routine, non-invasive respiratory mechanics measurements obtained as part of standard weaning assessment, with no additional risk or intervention beyond usual ICU care.
Treatment groups
Trial outcomes
Primary outcomes
Predictive Value of the Sarcopenia Index for Predicting Weaning Success
Area under the ROC curve (AUC), sensitivity, and specificity of the Sarcopenia Index (serum creatinine/serum cystatin C × 100) in predicting successful weaning from invasive mechanical ventilation.
Secondary outcomes
Association Between Sarcopenia Index and Reintubation
Comparison of Sarcopenia Index values (serum creatinine/serum cystatin C × 100) measured at the spontaneous breathing trial between patients who required reintubation or new non-invasive mechanical ventilation (NIMV) support and those who did not, within 48 hours post-extubation.
Locations
Sponsors and contacts
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