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

LunGuard

Status: Unknown

Conditions: Gastro-esophageal Reflux

Treatments: Device: ConvaTec Levin Duodenal Tube; Device: Peristaltic Feeding Tube

Study type: Interventional

Funder types: Industry

Identifiers

NCT02609620

PROT-150630835CTIL

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment

Experimental group

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

Treatment:

Device: Peristaltic Feeding Tube

Control

Active Comparator group

Description:

Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.

Treatment:

Device: ConvaTec Levin Duodenal Tube