Ultrasonographic Evaluation of Diaphragm and Accessory Respiratory Muscles During Weaning in ICU Patients With Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Weaning Failure
研究概览
简要总结
Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes.
This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality.
Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.
详细描述
This study is designed as a prospective, observational, single-center cohort study conducted in the intensive care unit (ICU). Adult patients (≥18 years) admitted to the ICU with pneumonia and receiving invasive mechanical ventilation via endotracheal intubation will be eligible for inclusion. Patients with known neuromuscular diseases, high cervical spinal cord injury, prior major neck, thoracic, or diaphragmatic surgery, acute thoracic trauma, pneumothorax, central nervous system pathology, or those receiving continuous neuromuscular blockade will be excluded.
Patients will be followed from ICU admission until one of the following outcomes occurs: successful extubation, tracheostomy, or ICU mortality. The first 24 hours after ICU admission will be defined as ICU Day 1. Disease severity and baseline characteristics will be assessed on ICU Day 1 using the APACHE II, SOFA, frailty index, and Charlson Comorbidity Index scores. Sedation level will be evaluated daily using the Richmond Agitation-Sedation Scale (RASS).
The first day on which the patient demonstrates meaningful spontaneous breathing effort, defined as a RASS score of -3 or higher, will be designated as Measurement Day 0. Ultrasonographic assessments of respiratory muscles will be performed daily for the first three days starting from Measurement Day 0 and every 48 hours thereafter until extubation or another study endpoint is reached. Days with deep sedation (RASS -4 or -5) will be recorded, and only structural muscle thickness measurements will be obtained on those days.
All ultrasound measurements will be performed at the bedside in the supine position under standardized conditions. Ventilator settings will be kept unchanged for at least 30 minutes prior to measurements, and no airway suctioning or position changes will occur within 15 minutes before data acquisition. For each parameter, measurements will be averaged over three consecutive respiratory cycles obtained during a stable ventilation period.
Diaphragm assessment will be performed on the right hemidiaphragm using a low-frequency convex probe at the zone of apposition between the 9th and 10th intercostal spaces along the anterior axillary line. End-expiratory diaphragm thickness will be recorded on all measurement days. On days with RASS ≥ -3, end-inspiratory thickness will also be measured, and diaphragm thickening fraction will be calculated.
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
- •Admission to the intensive care unit with a diagnosis of pneumonia
- •Receiving invasive mechanical ventilation via endotracheal intubation
- •Expected to undergo a weaning process from mechanical ventilation
- •Written informed consent obtained from the patient or legally authorized representative
排除标准
- •Known neuromuscular disease affecting respiratory muscles
- •High cervical spinal cord injury
- •History of major neck, thoracic, or diaphragmatic surgery
- •Acute thoracic trauma or pneumothorax
- •Central nervous system pathology affecting respiratory drive
- •Continuous neuromuscular blocking agent use
- •Pregnancy
研究组 & 干预措施
Pneumonia ICU Patients on Invasive Mechanical Ventilation
This cohort includes adult intensive care unit patients admitted with pneumonia who are receiving invasive mechanical ventilation via endotracheal intubation. All participants will undergo serial bedside ultrasonographic assessments of the diaphragm, parasternal intercostal muscles, and anterior scalene muscles during the weaning process. No therapeutic intervention is assigned as part of the study, and all clinical management decisions, including ventilator settings and weaning strategies, are determined by the treating ICU team according to standard care.
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
Weaning Failure
时间窗: From Measurement Day 0 until ICU discharge, up to 72 hours after extubation
Weaning failure is defined as the need for reintubation within 72 hours after planned extubation, requirement for tracheostomy, or death occurring in the intensive care unit before successful liberation from invasive mechanical ventilation.
次要结局
- Diaphragm Thickening Fraction (TFdi)(From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.)
- Parasternal Intercostal Muscle Thickening Fraction (TFic)(From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.)
- Anterior Scalene Muscle Thickening Fraction (STF)(From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.)
- Respiratory Drive and Weaning Indices(From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.)
- Ventilator Parameters During Weaning(From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.)
研究者
Gürcan Güler
Principal Investigator
Bursa Sevket Yilmaz Training and Research Hospital