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

Gastro-esophageal Reflux Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02609620
• Other study ID #: PROT-150630835CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2015
• Last updated: December 30, 2015
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: LunGuard Ltd.
• Contact: Adi Ickowicz
• Phone: +97239233666
• Email: adi[@]medicsense.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastro-esophageal Reflux
• Gastroesophageal Reflux

Intervention

Device:
• Peristaltic Feeding Tube

• ConvaTec Levin Duodenal Tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LunGuard Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of gastro-esophageal reflux (GER) by 30%		12-24 hours	No
Primary	Continuous esophageal pressure monitoring		12-24 hours	Yes
Primary	Successful introduction, positioning and removal of the device		12-24 h	Yes
Primary	Successful enteral feeding		12-24 hours	Yes
Secondary	Reduction of ventilator associated pneumonia (VAP)		12-24 hours	No
Secondary	Reduction of micro-aspirations		12-24 hours	No