Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube (PFT)
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
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
- 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 ]
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
|Contact: Adi Ickowicz||+97239233666 ext email@example.com|
|Contact: Gilat Mor||+97239233666 ext firstname.lastname@example.org|
|Principal Investigator:||Philip Biderman, MD||Bellinson Hospital|