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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02609620

Acronym

PFT

Enrollment

Registered

2015-11-20

Start date

2015-12-31

Completion date

2016-10-31

Last updated

2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal Reflux

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.

Interventions

DEVICEPeristaltic Feeding Tube

DEVICEConvaTec Levin Duodenal Tube

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactAdi Ickowicz

adi@medicsense.com+97239233666

Backup ContactGilat Mor

gilat@medicasense.com+97239233666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026