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.
研究组 & 干预措施
Treatment
In the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT
干预措施: Peristaltic Feeding Tube (Device)
Control
Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.
干预措施: ConvaTec Levin Duodenal Tube (Device)
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)