Electrical Impedance Tomography During Spontaneous Breathing Trial and Extubation Failure in Critically Ill Patients: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from extubation (SB_0)
研究概览
简要总结
Weaning is the entire process aimed at liberating patients from mechanical ventilation and endotracheal intubation. Weaning should be considered as early as possible in order to reduce the time spent in invasive mechanical ventilation (iMV), which is associated with morbidity and mortality. To verify if patients are ready to be extubated, a spontaneous breathing trial (SBT) is performed. At this stage some clinical indices and objective parameters are evaluated, such as the breathing pattern, gas exchange, haemodynamic stability and patient's comfort. In case of SBT success, the patient can be extubated. However, a post-extubation respiratory failure can occur within the first 48 hours after extubation, thus making extubation unsuccessful. Some patients considered at risk for post-extubation respiratory failure benefit from the application of non-invasive ventilation (NIV) after extubation. Early characterization of these patients is crucial to improve their clinical outcomes.
Electrical Impedance Tomography (EIT) has been introduced in clinical practice as a non-invasive bedside monitoring tool to evaluate the aeration and ventilation of different lung regions. EIT has been proposed to guide ventilator settings adjustments in critically ill patients and to monitor prolonged weaning. However, the potential of EIT to assess SBT and after extubation in a general ICU population has never been evaluated insofar.
The present study aims to describe the modifications of lung aeration, ventilation and inhomogeneity occurring during SBT and after extubation in a general population of critically ill patients at the first SBT attempt.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Glasgow Coma Scale ≥8
- •presence of clearly audible cough during suctioning with need for tracheal suctioning ≤2/hour
- •normal sodium blood values
- •core temperature <38.5° during the previous 8 hours
- •Arterial partial pressure of oxygen to inspired oxygen fraction (PaO2/FiO2) ≥200 mmHg, with a Positive End Expiratory Pressure ≤5 cmH2O and FiO2 ≤0.4
- •stable cardiovascular status (i.e., HR ≤140 beats/min, sBP between 90 and 160 mmHg without need for vasopressin, epinephrine or norepinephrine infusion, or with dopamine or dobutamine infusion ≤5 mcg/kg/min)
- •cuff leak volume >110 mL
排除标准
- •major heart arrhythmias or cardiac ischemia
- •pneumothorax or emphysema
- •recent (1 week) thoracic surgery
- •presence of chest burns
- •pregnancy
- •inclusion in other research protocols
结局指标
主要结局
Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from extubation (SB_0)
时间窗: At 5 minutes after extubation (SB_0)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Inhomogeneity Index (GI) at baseline
时间窗: At baseline during Pressure Support Ventilation
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute of Spontaneous Breathing Trial (SBT_0)
时间窗: At 5 minutes of Spontaneous Breathing Trial (SBT)
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of end-expiratory lung impedance (dEELI) from baseline at last 30 minute after extubation (SB_30)
时间窗: At 30 minutes after extubation
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of tidal volume in percentage (dVt%) from baseline at last 5 minute of SBT (SBT_0)
时间窗: At 5 minutes of spontaneous breathing trial (SBT_0)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of tidal volume in percentage (dVt%) from baseline from baseline at 30 minute of Spontaneous Breathing Trial (SBT_30)
时间窗: At the last 5 minutes of Spontaneous Breathing Trial (SBT) (SBT_30)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of tidal volume in percentage (dVt%) from baseline at last 30 minute after extubation (SB_30)
时间窗: At 30 minutes after extubation (SB_30)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Inhomogeneity Index (GI) after 30 minutes of the Spontaneous Breathing Trials (SBT_30)
时间窗: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Inhomogeneity Index (GI) after 30 minutes from extubation (SB_30)
时间窗: At 30 minutes after extubation (SB_30)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Change of end-expiratory lung impedance (dEELI) from baseline at last 5 minute of Spontaneous Breathing Trial (SBT_30)
时间窗: At the last 5 minutes of Spontaneous Breathing Trial (SBT)
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute after extubation (SB_0)
时间窗: At 5 minutes after extubation
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Inhomogeneity Index (GI) after 5 minutes of the Spontaneous Breathing Trials (SBT_0)
时间窗: At 5 minutes of Spontaneous Breathing Trial (SBT_0)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Inhomogeneity Index (GI) after 5 minutes from extubation (SB_0)
时间窗: At 5 minutes after extubation (SB_0)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
次要结局
- the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes after extubation (SB_0)(At 5 minutes after extubation (SB_0))
- the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 30 minutes after extubation (SB_30)(At 30 minutes after extubation (SB_30))
- Arterial Blood Gases at baseline(At baseline during Pressure Support Ventilation)
- Arterial Blood Gases at SBT_30(At 30 minutes of Spontaneous Breathing Trial (SBT_30))
- Arterial Blood Gases at SB_30(At 30 minutes after extubation (SB_30))
- the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at baseline(At baseline during Pressure Support Ventilation)
- the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at SBT_30(At 30 minutes of Spontaneous Breathing Trial (SBT_30))
- the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes of Spontaneous Breathing Trial (SBT_0)(At 5 minutes of Spontaneous Breathing Trial (SBT_0))
研究者
Federico Longhini
Associate Professor
University Magna Graecia