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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by E-Motion Medical Ltd.
Sponsor:
Collaborator:
Clinical Evaluation Research Unit at Kingston General Hospital
Information provided by (Responsible Party):
E-Motion Medical Ltd.
ClinicalTrials.gov Identifier:
NCT02515123
First received: July 31, 2015
Last updated: January 17, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Critically Ill Malnutrition Device: E-Motion System Device: Sham E-Motion System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-stay ICU Patients. A Multicenter, Phase II, Sham-controlled, Randomized Trial. The PROPEL Study

Further study details as provided by E-Motion Medical Ltd.:

Primary Outcome Measures:
  • Adequacy of enteral nutrition [ Time Frame: 7 days ]
    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).


Secondary Outcome Measures:
  • Time from intervention start to delivery of 80% prescribed energy and protein [ Time Frame: 7 days ]
    Time (in days) from start of intervention up to delivery of 80% of the calories and/or protein prescribed to the patient in a given day.

  • Proportion of subjects achieving >80% enteral nutrition intake [ Time Frame: 7 days ]
    Percent of subjects achieving enteral nutrition intake greater than 80% of the amount of calories and/or protein prescribed for the patient each day.


Other Outcome Measures:
  • Pepsin concentration [ Time Frame: 7 days ]
    Pepsin concentration in samples taken daily by ETA (ELISA immunoassay), indicating presence of gastric content in lungs.

  • microbiological analysis of endotracheal aspirates [ Time Frame: 7 days ]
    Bacterial culture in samples taken daily by ETA.

  • ICU Length of Stay [ Time Frame: 28 days ]
    Number of days from admission to the ICU until discharge from the ICU.

  • Pneumonia [ Time Frame: 28 days ]
    Pneumonia infection, as determined by the PI

  • Ventilator Free Days [ Time Frame: 28 days ]
    Ventilator-free days (number of days alive and free of mechanical ventilation in the first 28 days).

  • Parenteral Nutrition [ Time Frame: 7 days ]
    Daily delivery of parenteral nutrition calories and/or protein administered.


Estimated Enrollment: 140
Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E-Motion System
E-motion tube + E-motion EPG 1000
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.

Sham Comparator: E-Motion Sham Decive
E-motion tube + SHAM E-motion EPG 1000
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.

Detailed Description:

Malnutrition in the ICU is a known cause for increased morbidity and mortality and providing artificial nutrition is part of standard care in ICUs worldwide. While malnutrition is a risk factor for adverse outcomes related to critical illness, what is more difficult to prove is the value of optimal amounts of nutrition. Nevertheless, large-scale observational studies of critically ill patients suggest that optimal amounts and timely provision of nutritional intake is associated with reduced infectious complications, duration of mechanical ventilation, and mortality, along with perceptions of faster physical recovery. Smaller RCTs demonstrate that greater nutrition intake is associated with improved weaning from mechanical ventilation while larger RCTs do suggest non-significant improvements in long-term physical functional performance (6 minute walk test at 12 months) and a significant improvement in 60-day quality of life. In contrast, there are large-scale RCTs that fail to demonstrate a positive treatment effect of enhanced nutritional intake. However, these trials have been criticized for study heterogeneous groups of low 'nutritional-risk' patients. Patients who benefit the most from optimal nutritional supplementation are high-nutritional risk. Recent data suggests that tolerating 80% of the prescribed amounts of protein and calories is associated with improved clinical outcome and may serve as a quality indicator for ICU practice. Currently, around the world, more than 75% of nutritionally-high risk patients are systematically underfed receiving less than 80% of prescribed amounts. Thus, the investigators conclude that greater efforts to improve nutrition intake in ICU patients are warranted.

Early enteral nutrition (EN) is supported by mechanistic data delineating its physiologic effects, which provide both non-nutritional and nutritional benefits to the critically ill patient. EN should be started as soon as possible following admission to the ICU in order to achieve the non-nutritional benefits and minimize the development of a protein-calorie deficit that frequently occurs during the first week of critical illness. The non-nutritional benefits are derived from several physiologic mechanisms that maintain structural and functional gut integrity, preventing increases in intestinal permeability. Immune mechanisms elicited by EN result in attenuation of oxidative stress and the inflammatory response while supporting the humoral immune system. Enteral feeding modulates metabolic responses that help decrease insulin resistance. The nutritional benefits are derived from delivery of exogenous nutrients, which provide sufficient protein and calories, deliver micronutrients and antioxidants, and maintain lean body mass.

Because many factors impede delivery of early EN in the ICU setting, patients routinely get approximately 50% of the calories and protein that are required. Our mission, at E-Motion Medical, is to improve outcome for critically ill patients by lowering their risk of infection and enabling them to have better nutritional intake. To achieve that, novel technology was developed that reduces gastric reflux and promotes GI motility, via electric stimulation to the esophageal mucosa. The investigators believe our technology will improve gastric emptying, reduce reflux and aspiration of gastric content, and enable more adequate delivery of enteral nutrition to critically-ill patients predisposed to delayed gastric emptying.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18-85 years of age.
  2. 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).
  3. Mechanically ventilated and expected to remain alive and invasively mechanically ventilated for an additional 48 hours or longer from the point of screening.
  4. Receiving EN or prescribed to receive EN.
  5. Written informed consent obtained from legal representative (the subject will not be competent to give it on their own).

Exclusion Criteria:

  1. Known esophageal varicies.
  2. Patient has admission diagnosis of gastroesophageal bleeding requiring transfusions.
  3. Patient is implanted with a cardiac pacemaker or implantable defibrillator.
  4. Patient has a gastric pacemaker.
  5. Patient is prescribed to have NAVA tube or has one in place.
  6. Patient is suffering from life-threatening arrhythmia or severe cardiomyopathy diagnosed clinically or severe congestive heart disease (NYHA 3/4)
  7. Patients with severe hepatic failure (e.g. Child Pugh class C cirrhosis) or acute fulminant hepatic failure. Gilbert's syndrome or asymptomatic gallstones will not result in exclusion.
  8. Lactating or pregnant females as determined by positive serum or urine hCG test prior to enrolment.
  9. Concomitant participation in another randomized trial of a novel biological or device (non-industry sponsored or academic randomized trials and observational studies are suitable for co-enrolment)
  10. Previous randomization in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02515123

Contacts
Contact: Amichay H Gross, MSc, MBA +972 50 220 2243 ahg@emotionmed.com
Contact: Julia Rothman, DMD +972 54 525 0676 jr@emotionmed.com

Locations
Canada, Alberta
Royal Alexandria Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Jim Kutsogiannis         
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada
Contact: Allan Garland, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Completed
Halifax, Nova Scotia, Canada
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada
Contact: Francois Marquis, MD         
Hopital Sacre-Coeur Recruiting
Montreal, Quebec, Canada
Contact: Martin Albert         
Sponsors and Collaborators
E-Motion Medical Ltd.
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit