NCT02609620

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

November 17, 2015

Last Update Submit

December 30, 2015

Conditions

Gastro-esophageal Reflux

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Reduction of ventilator associated pneumonia (VAP)

    12-24 hours

  • Reduction of micro-aspirations

    12-24 hours

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Peristaltic Feeding TubeDEVICE
Treatment
ConvaTec Levin Duodenal TubeDEVICE
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Philip Biderman, MD

    Bellinson Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Ickowicz

CONTACT

+97239233666adi@medicsense.com

Gilat Mor

CONTACT

+97239233666gilat@medicasense.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

December 31, 2015

Record last verified: 2015-12