Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Patients well-being
研究概览
简要总结
There was no evidence to suggest that a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. However, there is no available data regarding the safety and efficacy of fasting approach in patients undergoing cardiac implantable electronic device (CIED) procedures. The aim of this study is to demonstrate that a non-fasting protocol is non-inferior in regard to safety to a fasting protocol (current practice) in patients undergoing cardiac device implantation procedures
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
- Double (Care Provider, 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
- •All patients >18 years undergoing elective implantation or generator exchange of cardiac implantable electronic devices
排除标准
- •Patients presenting with an acute unstable condition (bradycardia < 30/min or temporary pacing wire)
- •Patients scheduled for deep sedation
- •Patients with increased intra-abdominal pressure (severe intra-abdominal tumors, severe ascites, very severe obesity: BMI>40 kg/m2).
结局指标
主要结局
Patients well-being
时间窗: During the first 24 hours after the procedure
Post-interventional patients well-being including (to be assessed by questionnaire with the help of a Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome): abdominal pain, thirst, mouth dryness, headache, anxiety, hunger, nausea, vomiting, tiredness and weakness, dizziness Incidence of Intra -procedural adverse events like emergency intubation and perioperative pulmonary aspiration vomiting)
次要结局
- Surgical site pain(During the first 24 hours after the procedure)
- Patients general satisfaction(During the first 24 hours after the procedure)
- Serum creatinine level(1 hour pre-procedural, during the first 24 hours after the procedure)
- Serum urea level(1 hour pre-procedural, during the first 24 hours after the procedure)
- Oxygen saturation(pre-intervention, and then every 15 minutes during the procedure)
- blood pH(1 hour pre-procedural)
- blood PaCo2(1 hour pre-procedural)
- Length of ICU stay(Up to 30 days)
- Length of hospital stay(Up to 30 days)
- Usage of sedatives(During the intervention)
- eGFR(1 hour pre-procedural, during the first 24 hours after the procedure)
- Blood pressure(pre-intervention, and then every 15 minutes during the procedure)
- blood sugar(1 hour pre-procedural, pre-intervention, 8 hours after procedure)
- Sodium(1 hour pre-procedural, pre-intervention, 8 hours after procedure)
- Usage of analgesics(During the intervention)
- Usage anti-vomiting agents(During the intervention)
- Usages of inotropic and vasopressor agents(During the intervention)
- Heart rate(pre-intervention, and then every 15 minutes during the procedure)
- blood HCO3(1 hour pre-procedural)
- Potassium(1 hour pre-procedural, pre-intervention, 8 hours after procedure)
- Incidence of death(During 30 days after the procedure)
- Sleep quality(During the first 24 hours after the procedure)
- Operation site infection rate(During 30 days after the procedure)