Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Success rate of weaning from mechanical ventilation in both groups
研究概览
简要总结
To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)
详细描述
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume), however, sensitivity and specificity for most variables are still variable in literature.
Multiple studies have found that patients tolerantof SBTs were found to have successful discontinuationsat least 77% of the time.
Causes of weaning failure include: airway and lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm dysfunction, and endocrine dysfunction .
Diaphragmatic dysfunction is a common cause of weaning failure , however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Critically ill patients intubated for more than 48 hours who are ready for weaning
排除标准
- •• Age < 18 years
- •surgical dressings over the right lower rib cage which would preclude ultrasound examination
- •patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic injury and diaphragmatic surgery
- •patients with neuromuscular diseases ( myasthenia gravis ,Muscular dystrophies ,Multiple sclerosis and Amyotrophic lateral sclerosis)
研究组 & 干预措施
Group S
weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:-
- Resolution of acute phase of disease for which patient was intubated
- Adequate cough
- Absence of excessive tracheobronchial secretions
B) Objective criteria:-
- Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200
- Respiratory rate <30
- PH and PaCO2 appropriate for patients' baseline respiratory status
- Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia
- HR<140 beats/minute
- Patient is arousable or Glasgow coma scale (GCS)>13
Group SD
weaning readiness will be evaluated with the following criteria:- A) Clinical assessment:-
- Resolution of acute phase of disease for which patient was intubated
- Adequate cough
- Absence of excessive tracheobronchial secretions
B) Objective criteria:-
- Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200
- Respiratory rate <30
- PH and PaCO2 appropriate for patients' baseline respiratory status
- Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia
- HR<140 beats/minute
- Patient is arousable or Glasgow coma scale (GCS)>13
C) Ultrasound criteria:-
• Diaphragmatic excursion >11 mm
干预措施: diaphragmatic ultrasound (Device)
结局指标
主要结局
Success rate of weaning from mechanical ventilation in both groups
时间窗: 48 Hours after weaning
(The trial will be considered a successful weaning trial if the patient passed 48 hours without the need for neither invasive nor non-invasive ventilation)
次要结局
- • Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables(baseline)
- • Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction(baseline)
- • Number of weaning trials prior to inclusion in the study(baseline)