NCT02515123

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

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

July 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 31, 2015

Last Update Submit

July 8, 2019

Conditions

Critically IllMalnutrition

Keywords

intensive care unitmalnutritionGI motilitynutritional intake

Outcome Measures

Primary Outcomes (1)

  • Adequacy of enteral nutrition

    The primary endpoints for this study are the average daily delivery of enteral nutrition in percentage of the amount of calories and protein prescribed for the patient).

    7 days

Secondary Outcomes (2)

  • Time from intervention start to delivery of 80% prescribed energy and protein

    7 days

  • Proportion of subjects achieving >80% enteral nutrition intake

    7 days

Other Outcomes (6)

  • Pepsin concentration

    7 days

  • microbiological analysis of endotracheal aspirates

    7 days

  • ICU Length of Stay

    28 days

  • +3 more other outcomes

Study Arms (2)

E-Motion System

EXPERIMENTAL

E-motion tube + E-motion EPG 1000

Device: E-Motion System

E-Motion Sham Decive

SHAM COMPARATOR

E-motion tube + SHAM E-motion EPG 1000

Device: Sham E-Motion System

Interventions

E-Motion SystemDEVICE

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.

E-Motion System
Sham E-Motion SystemDEVICE

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.

E-Motion Sham Decive

Eligibility Criteria

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

You may qualify if:

  • Male or female, 18-85 years of age.
  • Patient is receiving a moderate to high dose of opioids, either continuously or intermittently and is expected to remain on opioids for an additional 48 hours from point of screening. By moderate to high dose, we mean at least 2 mg/h (or 48 mg/day) of morphine or equivalent (e.g., 20 µg/h fentanyl and 0.5 mg/h of hydromorphone).
  • Mechanically ventilated and expected to remain alive and invasively mechanically ventilated for an additional 48 hours or longer from the point of screening.
  • Receiving EN or prescribed to receive EN.
  • Written informed consent obtained from legal representative (the subject will not be competent to give it on their own).

You may not qualify if:

  • Mechanical ventilation start time in your ICU to time of screening is more than 72 hours
  • Subject has a contraindication to enteral feeding (i.e., ongoing bowel obstruction or perforation).
  • Subject requires small bowel feeding at point of screening.
  • Subject requires feeding tube placed operatively or percutaneously.
  • Subject requires total parenteral nutrition at point of screening.
  • Subject has a known diagnosis of gastroparesis requiring outpatient motility agents (e.g. diabetic gastroparesis).
  • Subject has contraindication to oro/nasogastric tube insertion, e.g. esophageal tumors, laryngectomy, etc.
  • Subject with known esophageal varices.
  • Subject has admission diagnosis of gastroesophageal bleeding requiring transfusions.
  • Subject is implanted with a cardiac pacemaker ; temporary pacemaker or is pacemaker dependent ; or implantable defibrillator.
  • Subject has a gastric pacemaker.
  • Subject is prescribed to have NAVA tube or has one in place.
  • Subject is suffering from life-threatening arrhythmia (atrial fibrillation \[AF} with rapid ventricular response; sustained VT; ventricular fibrillation \[VF\]; cardiac arrest; any cardiac arrhythmia that may cause the patient to be hemodynamically instable); severe cardiomyopathy diagnosed clinically or severe congestive heart disease (NYHA 3/4).
  • A requirement for continuous EEG monitoring at the time of screening
  • Lactating or pregnant females as determined by positive serum or urine hCG test prior to enrolment.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Royal Alexandria Hospital

Edmonton, Alberta, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

London Health Sciences

London, Ontario, N6A 5W9, Canada

Location

Ottawa OHRI

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Montreal General Hospital

Montreal, Quebec, R2H 2A6, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Hopital Sacre-Coeur

Montreal, Quebec, Canada

Location

Hoptial L'ENfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

University of Sherbrooke Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (3)

  • Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.

    PMID: 19572118BACKGROUND

  • Heyland DK, Stephens KE, Day AG, McClave SA. The success of enteral nutrition and ICU-acquired infections: a multicenter observational study. Clin Nutr. 2011 Apr;30(2):148-55. doi: 10.1016/j.clnu.2010.09.011. Epub 2010 Oct 25.

    PMID: 20971534BACKGROUND

  • Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d.

    PMID: 21705881BACKGROUND

Related Links

MeSH Terms

Conditions

Critical IllnessMalnutrition

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Daren K Heyland, MD

    Clinical Evaluation Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 4, 2015

Study Start

February 1, 2016

Primary Completion

February 15, 2018

Study Completion

July 4, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

CA(11)