Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastro-esophageal Reflux

Intervention / Treatment
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* Device: Peristaltic Feeding Tube
* Device: ConvaTec Levin Duodenal Tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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 | Device: Peristaltic Feeding Tube<br> <br> |
| Active Comparator: Control<br>Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard. | Device: ConvaTec Levin Duodenal Tube<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of gastro-esophageal reflux (GER) by 30% |  | 12-24 hours | 
| Continuous esophageal pressure monitoring |  | 12-24 hours | 
| Successful introduction, positioning and removal of the device |  | 12-24 h | 
| Successful enteral feeding |  | 12-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ventilator associated pneumonia (VAP) |  | 12-24 hours | 
| Reduction of micro-aspirations |  | 12-24 hours |