Clinical trial NCT02609620: Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro-esophageal Reflux
Lead sponsor: LunGuard Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of gastro-esophageal reflux (GER) by 30%
timeFrame: 12-24 hours
measure: Continuous esophageal pressure monitoring
timeFrame: 12-24 hours
measure: Successful introduction, positioning and removal of the device
timeFrame: 12-24 h
measure: Successful enteral feeding
timeFrame: 12-24 hours
Secondary outcomes:
measure: Reduction of ventilator associated pneumonia (VAP)
timeFrame: 12-24 hours
measure: Reduction of micro-aspirations
timeFrame: 12-24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Bellinson Hospital
name: Philip Biderman, MD
role: PRINCIPAL_INVESTIGATOR
References: