A Single-Center, Open Label, Randomized, Controlled Study to Evaluate the Safety & Initial Efficacy of the LunGuard PFT System, and Its Impact on GER in Enteral-Fed, Sedated and Mechanically Ventilated Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Continuous esophageal pressure monitoring
研究概览
简要总结
This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.
Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.
The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent.
- •Patients who are expected for at least 12 hours to be:
- •Mechanically ventilated and sedated.
- •Requiring a nasogastric tube.
- •Included are:
- •Patients who have undergone tracheostomy.
- •Patients who require use of pro-kinetic drugs and proton pump inhibitors.
- •All levels of Gastric Residual Volume (GRV)
排除标准
- •• Patients with a contraindication for insertion of a nasogastric tube.
- •Patients with a known esophageal obstruction, preventing passage of the device.
- •Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)
- •Acute and severe coagulation disorders
- •(INR> 2 or platelets below 30,000)
- •Diabetic patients with documented gastrointestinal neuropathy
- •Pregnancy or lactation
- •Allergy to Silicon
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
结局指标
主要结局
Continuous esophageal pressure monitoring
时间窗: 12-24 hours
Successful introduction, positioning and removal of the device
时间窗: 12-24 h
Successful enteral feeding
时间窗: 12-24 hours
Reduction of gastro-esophageal reflux (GER) by 30%
时间窗: 12-24 hours
次要结局
- Reduction of micro-aspirations(12-24 hours)
- Reduction of ventilator associated pneumonia (VAP)(12-24 hours)