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

L

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)

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

Trial contacts and locations

0

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Central trial contact

Adi Ickowicz; Gilat Mor

Data sourced from clinicaltrials.gov

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