The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- DD-48
研究概览
简要总结
This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.
详细描述
Patient was enrolled in the first day receiving mechanical ventilation in ICU. Patient was included to group A or group B. Group A patient will receive tidal volume of 6 ml/kg and group B patient will receive tidal volume of 10 ml/kg. The assignment was randomized. Followed for 3 days. After 24, 48, and 72 hours, patient blood will be collected to measure the interleukin value, and diaphragm dysfunction will be observed by the use of ultrasonography by expert doctor from radiology department. Data will be analyzed statistically if there is an effect of tidal volume difference on diaphragm dysfunction and interleukin-6 as marker of inflammation. The minimal sample of patient is 44 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to which group they belong and they have given consent to that.
The person assigning patients to each group is the research assistant. The person setting the mechanical ventilator is the anesthesiology resident. The person assessing outcome with ultrasound is radiology department staff, who does not know which group the patient belong.
The person assessing outcome of interleukin is laboratory personnel, who does not know which group the patient belong.
The person collecting and freezing data into worksheet is the research assistant.
The person analyzing final data is the primary investigator.
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
- •Minimum age 18 years old
- •Critically ill patients
排除标准
- •Patient with ARDS (PaO2/FiO2 <200)
- •Pregnant woman
- •Patient with history of cardiac or thorax surgery 14 days prior to admission
- •Patient with severe peripheral musculoskeletal conditions
- •Patient with prolonged in-hospital stay (>2 weeks) in the last 3 months
结局指标
主要结局
DD-48
时间窗: 48 hours after mechanical ventilation
Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
DD-24
时间窗: 24 hours after mechanical ventilation
Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
DD-72
时间窗: 72 hours after mechanical ventilation
Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.
次要结局
- IL-6-48(48 hours after mechanical ventilation)
- IL-6-72(72 hours after mechanical ventilation)
- IL-6-24(24 hours after mechanical ventilation)
研究者
Darma Putra Sitepu
Anesthesiologist Consultant In-Training, Principal Investigator
Dr Cipto Mangunkusumo General Hospital