A Randomized Controlled Study on Continuous Monitoring of Cardiac Index Variability to Guide Patients With Perioperative Myocardial Injury to Wean From Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- weaning success rate
研究概览
简要总结
The goal of this prospective randomized controlled clinical trail is to explore the value of integrating continuous cardiac index variability indicators with existing weaning standards to guide perioperative myocardial injury patients weaning. The main question it aims to answer is: whether the introduction of new indicators for weaning standards can improve the success rate of weaning. Treatment that'll be given to participants is: the cardiac index (CI) is continuously monitored from 15-30 minutes prior to the start of the weaning from ventilation. Participants who increase their CI by more than 30% can have their tracheal intubation removed. Researchers will compare the weaning success rate of CI group and control group.
详细描述
In this study, investigator'll recruit participants of perioperative myocardial injury as the research objects, the continuous cardiac index variability index was added to the current traditional weaning standard to form a new weaning standard. In this prospective, randomized, and controlled study, the impact of the new weaning standard and the traditional weaning standard on weaning failure rate was compared. Whether the new weaning standard is superior to ordinary weaning standards is evaluated in terms of participants prognosis, incidence of complications, and medical resource consumption.
Quality assurance plan that addresses data validation and registry procedures: Two researchers who have received unified training record and register participant data separately, and a third researcher conducts weekly data checks to compare data entered into the registry against predefined rules for range. The source data will be verified to assess the accuracy, completeness of registry data by comparing the data to medical records and paper or electronic case report forms.
Standard Operating Procedures to address participant recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be formulated before recruit.
The estimation of sample size is based on testing that the new weaning standard is superior to traditional standards in improving weaning success rate. According to previous reports and our previous study data, the sample size was calculated using PASS 11.0 software. The results showed that 91 cases were needed in each group. Considering a 5% dropout rate, 100 participants were included in each group for a total of 200 participants.
Plan for missing data: Investigator will verify the data monthly and recruit sufficient participants according to the research protocol and statistical requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perioperative myocardial injury patients
- •Age>18 years;
- •Acute Physiology and Chronic Health Evaluation II (APACHEII)>8 ;
- •The weaning process has not yet started after surgery;
- •Expected postoperative cumulative mechanical ventilation time>24 hours.
排除标准
- •Pregnancy or childbirth less than 42 days;
- •Patients and their families are unable to cooperate with treatment;
- •The cumulative actual mechanical ventilation time after surgery is ≤ 24 hours;
- •Interruption of mechanical ventilation treatment due to death or other reasons before entering the weaning process;
- •Patients who retain artificial airways after weaning;
- •Patients who plan to start non-invasive mechanical ventilation treatment immediately after weaning.
研究组 & 干预措施
CI group
the cardiac index (CI) is continuously monitored during the weaning process
干预措施: cardiac output index monitor (Diagnostic Test)
control group
No intervention measures
结局指标
主要结局
weaning success rate
时间窗: through study completion, an average of 1 year
次要结局
- in-ICU mortality(through study completion, an average of 1 year)
- 28 day mortality(through study completion, an average of 1 year)
- length of stay in ICU(through study completion, an average of 1 year)
- The incidence of ventilator-associated pneumonia(through study completion, an average of 1 year)
研究者
Li Shu
associate professor
Peking University People's Hospital