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NOT YET RECRUITING
NCT07844421

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

Sponsor: Kocaeli City Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-11-15

Completion Date

2027-12-15

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

OTHER

sarcopenia index

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.

OTHER

diaphragma ultrasound

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.

OTHER

parameters of mechanical ventilation (MV)

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.