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

PHASE2CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

February 15, 2018

Study Completion Date

July 4, 2019

Conditions
Critically IllMalnutrition
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.

Trial Locations (11)

Unknown

Royal Alexandria Hospital, Edmonton

St. Boniface Hospital, Winnipeg

Queen Elizabeth II Health Sciences Centre, Halifax

Ottawa OHRI, Ottawa

Sunnybrook Health Sciences Centre, Toronto

Hopital Maisonneuve-Rosemont, Montreal

Hopital Sacre-Coeur, Montreal

N6A 5W9

London Health Sciences, London

R2H 2A6

Montreal General Hospital, Montreal

G1J 1Z4

Hoptial L'ENfant Jesus, Québec

J1H 5N4

University of Sherbrooke Fleurimont, Sherbrooke

Sponsors
All Listed Sponsors
collaborator

Clinical Evaluation Research Unit at Kingston General Hospital

OTHER

lead

E-Motion Medical Ltd.

INDUSTRY

NCT02515123 - Promotion of Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in ICU Patients. | Biotech Hunter | Biotech Hunter