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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Reduction of gastro-esophageal reflux (GER) by 30%
Time frame: 12-24 hours
Continuous esophageal pressure monitoring
Time frame: 12-24 hours
Successful introduction, positioning and removal of the device
Time frame: 12-24 h
Successful enteral feeding
Time frame: 12-24 hours
Reduction of ventilator associated pneumonia (VAP)
Time frame: 12-24 hours
Reduction of micro-aspirations
Time frame: 12-24 hours
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