Gastro-esophageal Reflux Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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