Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Predictive Value of the Sarcopenia Index for Predicting Weaning Success
研究概览
简要总结
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.
详细描述
This study will enroll adult patients undergoing invasive mechanical ventilation in the ICU. Serum creatinine and cystatin C will be measured at the time of the spontaneous breathing trial (SBT) to calculate SI . Diaphragm ultrasound parameters (DTF and DE) will be obtained at the SBT, along with other standard weaning parameters (e.g., rapid shallow breathing index, and other clinically used indices). Weaning success will be defined as the absence of reintubation or need for ventilatory support within 48-72 hours after extubation.
The primary aim is to evaluate the diagnostic accuracy of SI, alone and in combination with diaphragm ultrasound parameters, in predicting weaning success using receiver operating characteristic (ROC) curve analysis, and to derive a population-specific SI cutoff value for this setting. Secondary aims include comparing SI's predictive performance to established weaning parameters and assessing correlations between SI and diaphragm ultrasound measurements. If validated, SI could offer clinicians a low-cost, widely available, and less operator-dependent adjunct or alternative to ultrasound-based assessment of weaning readiness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
- •Neuromuscular disease
- •High cervical spinal cord injury
- •Terminal-stage malignancy
- •Chronic home mechanical ventilator dependency
- •Diaphragmatic paralysis
- •Renal replacement therapy
- •Chronic kidney disease on a regular dialysis program
- •Significant renal function fluctuation within 48 hours prior to weaning
研究组 & 干预措施
Weaning Success
Patients who met weaning criteria and were successfully extubated following a spontaneous breathing trial (SBT), without reintubation or need for non-invasive mechanical ventilation (NIMV) within 48 hours post-extubation.
In this group, diaphragm ultrasonography (diaphragm excursion, end-expiratory and end-inspiratory diaphragm thickness, diaphragm thickening fraction), classical weaning parameters (RSBI, NIF, P0.1), and the Sarcopenia Index (serum creatinine/serum cystatin C × 100) were recorded at the time of the SBT.
干预措施: sarcopenia index (Other)
Weaning Success
Patients who met weaning criteria and were successfully extubated following a spontaneous breathing trial (SBT), without reintubation or need for non-invasive mechanical ventilation (NIMV) within 48 hours post-extubation.
In this group, diaphragm ultrasonography (diaphragm excursion, end-expiratory and end-inspiratory diaphragm thickness, diaphragm thickening fraction), classical weaning parameters (RSBI, NIF, P0.1), and the Sarcopenia Index (serum creatinine/serum cystatin C × 100) were recorded at the time of the SBT.
干预措施: diaphragma ultrasound (Other)
Weaning Success
Patients who met weaning criteria and were successfully extubated following a spontaneous breathing trial (SBT), without reintubation or need for non-invasive mechanical ventilation (NIMV) within 48 hours post-extubation.
In this group, diaphragm ultrasonography (diaphragm excursion, end-expiratory and end-inspiratory diaphragm thickness, diaphragm thickening fraction), classical weaning parameters (RSBI, NIF, P0.1), and the Sarcopenia Index (serum creatinine/serum cystatin C × 100) were recorded at the time of the SBT.
干预措施: parameters of mechanical ventilation (MV) (Other)
Weaning Failure
Patients who, despite meeting weaning criteria and undergoing an SBT, required reintubation or new NIMV support within 48 hours post-extubation, classified as unsuccessful weaning. The same diaphragm ultrasonography parameters, classical weaning parameters, and Sarcopenia Index measurements were recorded at the time of the SBT for comparison with the Weaning Success group.
干预措施: sarcopenia index (Other)
Weaning Failure
Patients who, despite meeting weaning criteria and undergoing an SBT, required reintubation or new NIMV support within 48 hours post-extubation, classified as unsuccessful weaning. The same diaphragm ultrasonography parameters, classical weaning parameters, and Sarcopenia Index measurements were recorded at the time of the SBT for comparison with the Weaning Success group.
干预措施: diaphragma ultrasound (Other)
Weaning Failure
Patients who, despite meeting weaning criteria and undergoing an SBT, required reintubation or new NIMV support within 48 hours post-extubation, classified as unsuccessful weaning. The same diaphragm ultrasonography parameters, classical weaning parameters, and Sarcopenia Index measurements were recorded at the time of the SBT for comparison with the Weaning Success group.
干预措施: parameters of mechanical ventilation (MV) (Other)
结局指标
主要结局
Predictive Value of the Sarcopenia Index for Predicting Weaning Success
时间窗: Through study completion, an avarage of 1 year
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.
次要结局
- Association Between Sarcopenia Index and Reintubation(Within 48 hours after extubation)
研究者
Hasan Berk Gönülalan
Medical Doctor
Kocaeli City Hospital