A multicenter randomized controlled trial comparing intermittent enteral feeding while in right lateral tilt position to standard care among mechanically ventilated adult Intensive Care Unit (ICU) patients

Not Applicable

• Conditions: Adult critically ill patients requiring invasive mechanical ventilation; Respiratory - Other respiratory disorders / diseases; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616000212459
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Patients who are receiving invasive mechanical ventilation (IMV) and are deemed likely to require IMV for at least the next 24 hours.
2) Age equal to or more than 18 years
3) Naso or Oro-gastric tube is in situ or its insertion is imminent

Exclusion Criteria

1) Patients with ICU stay of more than 72 hours after initiation of IMV
2) Moribund patients or those patients with an imminent risk of death within the next 48 hours.
3) Patients who are not deemed fit for enteral feeding by the treating team.
4) Patients with history of esophageal or gastric surgery within the last month.
5) Patients with gastric banding procedure
6) Patients with acute starvation (i.e., no nutrition for >5 days)
7) Patients who had intestinal resection with less than 200 cm of small intestine remaining.
8) Patients with known hiatus hernia.
9) Patients with feeding jejunostomy tubes in situ.
10) Patients receiving total parenteral nutrition.
11) Patients who suffer from cachexia or severely malnourished state
12) Patients with history of malabsorptive or gastrointestinal motility disorders (e.g. irritable bowel syndrome or inflammatory bowel diseases or diabetic gastroparesis)
13) Patients in whom semi-recumbent right lateral position is contraindicated or not feasible.
14) Treating clinician lacks equipoise or believes that bolus/ intermittent feeding is not in patient’s best interests

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of gastrointestinal intolerance (a composite outcome of vomiting*, diarrhoea** or constipation***; which would be assessed on review of medical records and with the help of a bedside vomiting and diarrhoea nursing observation chart):<br> <br>* Vomiting will be defined as gastric contents detected in or outside oral cavity, including spontaneous regurgitation of enteral feeds, but not the regurgitation associated with gag reflex such as during oral cavity care. <br>** Diarrhoea will be defined as >5 liquid stools or an estimated stool volume of >1000 ml within a 24-hour period. <br>*** Constipation will be defined as failure to pass any stools for >3 consecutive full calendar days.<br>[Time of discharge from ICU or 14 days after randomisation, whichever is earlier]