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

December 30, 2015 updated by: LunGuard Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Active Comparator: Control
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LunGuard Ltd.

Investigators

  • Principal Investigator: Philip Biderman, MD, Bellinson Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT-150630835CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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