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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609620
Recruitment Status : Unknown
Verified December 2015 by LunGuard Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
LunGuard Ltd.

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.


Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Device: Peristaltic Feeding Tube Device: ConvaTec Levin Duodenal Tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : December 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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



Primary Outcome Measures :
  1. Reduction of gastro-esophageal reflux (GER) by 30% [ Time Frame: 12-24 hours ]
  2. Continuous esophageal pressure monitoring [ Time Frame: 12-24 hours ]
  3. Successful introduction, positioning and removal of the device [ Time Frame: 12-24 h ]
  4. Successful enteral feeding [ Time Frame: 12-24 hours ]

Secondary Outcome Measures :
  1. Reduction of ventilator associated pneumonia (VAP) [ Time Frame: 12-24 hours ]
  2. Reduction of micro-aspirations [ Time Frame: 12-24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609620


Contacts
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Contact: Adi Ickowicz +97239233666 ext 0 adi@medicsense.com
Contact: Gilat Mor +97239233666 ext 4 gilat@medicasense.com

Sponsors and Collaborators
LunGuard Ltd.
Investigators
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Principal Investigator: Philip Biderman, MD Bellinson Hospital

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Responsible Party: LunGuard Ltd.
ClinicalTrials.gov Identifier: NCT02609620    
Other Study ID Numbers: PROT-150630835CTIL
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases