Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKocaeli City Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • sarcopenia index

    Other intervention

    A 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 intervention

    Non-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 intervention

    Standard 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

80 Participants
are divided into 2 treatment groups
Group A: Weaning Success3 interventions
Group B: Weaning Failure3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an avarage of 1 year

Secondary outcomes

1

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.

Time frame
Within 48 hours after extubation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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