Daily Lung Ultrasound Assisting Weaning From Mechanical Ventilation in Difficult-to-wean Adult Patients - a Randomized Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Time in mechanical ventilation
研究概览
简要总结
Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult patients. In this randomized trial, standardized lung ultrasound will be performed daily asssociated with standardized interventions aiming to decrease the total time in mechanical ventilation.
详细描述
This trial will be performed in two intensive care units (ICUs). After randomization, all patients in the intervention group will undergo daily lung ultrasounds before the next spontaneous breathing trial. The results from the lung ultrasound will indicate specific interventions to facilitate weaning:
- No sign of lung sliding (ultrasound finding suggestive of pleural movement): prompt evaluation for pneumothorax or mainstream intubation will be indicated;
- normal lung ultrasound (ultrasound A profile): the patient will be evaluated for deep vein thrombosis / pulmonary embolism and/or for reversible airway obstruction (e.g. uncontrolled asthma or COPD [Chronic Obstructive Pulmonary Disease] exacerbation)- followed by appropriate treatment. If the patient has COPD, non invasive mechanical ventilation must be used as mode of discontinuing mechanical ventilation;
- lung ultrasound shows pulmonary edema (ultrasound B profile): cardiogenic pulmonary edema will be differentiated from acute Respiratory Distress Syndrome (ARDS) - followed by appropriate treatment (e.g. a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial);
- lung ultrasound shows asymmetrical patterns (ultrasound AB profile or Pulmonary Consolidation): the possibility of an uncontrolled infection will be investigated;
- presence of simple pleural effusion: diuretics will be indicated (for a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial) or thoracocentesis at description of the assistant team;
- presence of complex pleural effusion: other image exam will be performed, and will be evaluated by the surgical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Difficult to Wean;
- •1 failure in the spontaneous breathing trial or 1 extubation failure
- •Adult patients (over 18 years old);
排除标准
- •Palliative Care;
- •Life expectancy under 90 days;
- •COPD Gold IV, Cirrhosis Child C, Metastatic Cancer with low performance, etc
- •Other weaning method than institutional protocol
研究组 & 干预措施
Control Group
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Pulmonary Interstitial Syndrome (Other)
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Abolish Lung Sliding (Other)
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Normal Lung Ultrasound (Other)
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Asymmetrical Lung Ultrasound (Other)
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Simple Pleural Effusion (Other)
Daily Lung Ultrasound
If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
干预措施: Complex Pleural Effusion (Other)
结局指标
主要结局
Time in mechanical ventilation
时间窗: from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)
次要结局
- Length of ICU stay(from icu admition until icu discharge, up to 2 months)
- Incidence of ventilation-associated pneumonia(until icu discharge, up to 2 months)
- Performance status at ICU's and Hospital's discharge(at icu's and hospital discharge, with an expected average of 4 weeks)
- Correlation between findings from ultrasound and other image techniques(after data collection (1 year) - retrospective review)
- Duration of Weaning(From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks)
- ICU's, Hospital's and 28-days mortality(until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks)
- Number of tracheostomies performed(patients follow-up will continue until weaning from mechanical support, up to 2 months)
研究者
Felippe Leopoldo Dexheimer Neto
M.D.
Hospital Ernesto Dornelles