Back to resultsSafety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube (PFT)
Primary Purpose
Gastro-esophageal Reflux
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peristaltic Feeding Tube
ConvaTec Levin Duodenal Tube
Sponsored by
About this trial
This is an interventional supportive care trial for Gastro-esophageal Reflux
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
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
Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.
Outcomes
Primary Outcome Measures
Reduction of gastro-esophageal reflux (GER) by 30%
Continuous esophageal pressure monitoring
Successful introduction, positioning and removal of the device
Successful enteral feeding
Secondary Outcome Measures
Reduction of ventilator associated pneumonia (VAP)
Reduction of micro-aspirations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02609620
Brief Title
Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
Acronym
PFT
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LunGuard Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-esophageal Reflux
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.
Intervention Type
Device
Intervention Name(s)
Peristaltic Feeding Tube
Intervention Type
Device
Intervention Name(s)
ConvaTec Levin Duodenal Tube
Primary Outcome Measure Information:
Title
Reduction of gastro-esophageal reflux (GER) by 30%
Time Frame
12-24 hours
Title
Continuous esophageal pressure monitoring
Time Frame
12-24 hours
Title
Successful introduction, positioning and removal of the device
Time Frame
12-24 h
Title
Successful enteral feeding
Time Frame
12-24 hours
Secondary Outcome Measure Information:
Title
Reduction of ventilator associated pneumonia (VAP)
Time Frame
12-24 hours
Title
Reduction of micro-aspirations
Time Frame
12-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Ickowicz
Phone
+97239233666
Ext
0
Email
adi@medicsense.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gilat Mor
Phone
+97239233666
Ext
4
Email
gilat@medicasense.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Biderman, MD
Organizational Affiliation
Bellinson Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
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