NCT02609620

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: LunGuard Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastro-esophageal Reflux

Interventions

Type	Name	Description
DEVICE	Peristaltic Feeding Tube
DEVICE	ConvaTec Levin Duodenal Tube

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-10-01
• First posted: 2015-11-20
• Last updated: 2015-12-31