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Promotion of Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in ICU Patients.

NCT02515123 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2019-07-10

No results posted yet for this study

Summary

Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as gastro-esophageal reflux, with both overt and micro pulmonary aspiration, which potentially increases the risk to nosocomial pneumonia. Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastro esophageal reflux, vomiting, aspiration, and VAP. Early and adequate enteral feeding in ICU patients is correlated with decreased overall infections rates, ventilator and intensive care unit (ICU) days, costs, and mortality.

This study is intended to assess the efficacy and safety of the E-Motion System (i.e. E-Motion tubeTM and E-Motion EPG 1000TM) in improving tolerance to enteral nutrition by inducing esophageal motion by means of electrical stimulation in ICU patients.

Conditions

  • Critically Ill
  • Malnutrition

Interventions

DEVICE

E-Motion System

E-Motion Tube: A disposable oro/nasogastric feeding tube fitted with stainless steel electrodes along its length that delivers the stimulation to the esophageal mucosa. E-motion EPG 1000: a durable, touchscreen operated, bedside control unit that generates the electric stimulation pattern and sends it via the feeding tube to the esophagus. By applying predetermined sequences of electrical stimulation to various locations along the esophagus asynchronous esophageal motion is induced, resulting is reduction of reflux and increased GI motility, enabling safer and better feeding.

DEVICE

Sham E-Motion System

The sham EPG will resemble the investigational EPG. The external shape, interface, lights, and switches will be exactly the same. The Sham device will emit a low intensity pulsation so that, it will not unblind the patient nor health care professional. In the event that unblinding does occur, we will take steps to mask the identity of the EPG by covering the number of the device with tape to prevent members of the clinical team becoming aware of which device is active or sham.

Sponsors & Collaborators

  • Clinical Evaluation Research Unit at Kingston General Hospital

    collaborator OTHER

  • E-Motion Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Daren K Heyland, MD · Clinical Evaluation Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-15
Completion
2019-07-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515123 on ClinicalTrials.gov