Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome in Mechanically Ventilated Patients With Sepsis in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Successful extubation
研究概览
简要总结
This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit
详细描述
After being informed about the study and giving written informed consent, Intubated and mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness (DT) and calculate diaphragm thickness fraction (DTF):
DT during inspiration - DT during expiration / DT during expiration
According to weaning outcome, patients will be divided into 2 groups:
- Successful weaning group
- Weaning failure group
By statistical analysis we will define the cut off value and area under curve (AUC) for DE and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for weaning from MV or not
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aging 18 - 60 years after written informed consent
- •Patients with sepsis on admission according to the new sepsis definition in 2016 (life-threatening organ dysfunction due to a dysregulated host response to infection)
- •Hemodynamically stable without or with low dose support
- •Patients on mechanical ventilation for at least 48 hours and not more than 1 week
- •Patients ready for start of weaning protocol, fully conscious, on continuous positive airway pressure (CPAP) mode with positive end expiratory pressure (PEEP) 3-5 Centimetre water (CmH2O), Pr. Supp. <15 CmH2O, Fio2 less than 60%, Respiratory rate less than 35 breath/min, partial oxygen pressure (PO2)/FIO2 >200, Rapid Shallow Breathing Index (RSBI) is less than 105
排除标准
- •Patients aged less than 18 years or more than 60 years old
- •Patients in septic shock, hemodynamically unstable or on high dose support
- •Patients on mechanical ventilation for more than 1 week or less than 48 hours
- •Patients not ready for start of weaning from mechanical ventilation
- •Patients with neuromuscular disorders
- •Pregnant females in the second and third trimester, patients with tense ascites or morbidly obese with body mass index more than 40 kg/m2
结局指标
主要结局
Successful extubation
时间窗: from start of SBT till 48 hours after extubation
extubation success or failure will depend on patient needs to MV during spontaneous breathing trial (SBT), or invasive or non-invasive ventilation within 48 hours after extubation according to: respiratory rate\>35/min, increased work of breathing, O2 saturation \<90% with fraction of inspired oxygen (FIO2)\>50%, new arrhythmias, increased heart rate\>20% or more than 140b/min, drop of 20 millimetre mercury (mmHg) or rise of 30 mmHg systolic blood pressure, increased systolic blood pressure \>180 mmHg in normotensive patient, change of 10 mmHg diastolic blood pressure and deterioration of blood gases value
次要结局
- need for tracheostomy(From start of SBT for 21 days)