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Critically IllPhase 2PROPELNCT02515123

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

A Phase 2 study testing E-Motion System in people with Critically Ill and Malnutrition, run by E-Motion Medical Ltd. at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Critically Ill, Malnutrition
What is being tested?
E-Motion System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
11 sitesCanada
Study dates
Feb 2016to 4 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Mechanical ventilation start time in your ICU to time of screening is more than 72 hours
  • Subject has a history of or had undergone esophageal or gastric surgery on this admission (lower abdominal surgery will not result in exclusion unless it carries a contraindication to enteral feeding).
  • 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.
Show all 19Show fewer
  • 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).
  • Subjects 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.
  • 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.
  • 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).
  • Previous randomization in this study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites
  • Royal Alexandria Hospital

    Edmonton, Alberta

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia

  • London Health Sciences

    London, Ontario, N6A 5W9

  • Montreal General Hospital

    Montreal, Quebec, R2H 2A6

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec

  • Hopital Sacre-Coeur

    Montreal, Quebec

  • Ottawa OHRI

    Ottawa, Ontario

  • Hoptial L'ENfant Jesus

    Québec, Quebec, G1J 1Z4

  • University of Sherbrooke Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • St. Boniface Hospital

    Winnipeg, Manitoba

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
E-Motion System, Sham E-Motion System
Keywords
intensive care unit, malnutrition, GI motility, nutritional intake
Medical subject headings
Critical Illness, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02515123
Study groupRoleWhat they receive
E-Motion SystemExperimentalE-motion tube + E-motion EPG 1000
Receives: Device: E-Motion System
E-Motion Sham DeciveSham comparatorE-motion tube + SHAM E-motion EPG 1000
Receives: Device: Sham E-Motion System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 7 days

Secondary outcomes (2)
  1. Time from intervention start to delivery of 80% prescribed energy and protein

    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.

    Measured: 7 days

  2. Proportion of subjects achieving >80% enteral nutrition intake

    Percent of subjects achieving enteral nutrition intake greater than 80% of the amount of calories and/or protein prescribed for the patient each day.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion15 Feb 2018
  4. Study completion4 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02515123
Sponsor's protocol ID
PROPEL (ICU-02)
Acronym
PROPEL
Status last verified
Jul 2019
First submitted
31 Jul 2015
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19572118
  • 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.

    PubMed 20971534
  • 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.

    PubMed 21705881

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E-Motion System in people with Critically Ill and Malnutrition, run by E-Motion Medical Ltd. at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequacy of enteral nutrition (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02515123, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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