Promotion of Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in ICU Patients.
Condition: Critically Ill; Malnutrition
MeSH terms: Malnutrition; Critical Illness
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): E-Motion System; Sham E-Motion System
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intensive care unit; malnutrition; GI motility; nutritional intake