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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000212459
Acronym
ICU-FM Study (ICU Feeding-Mode Study )
Enrollment
120
Registered
2016-02-17
Start date
2016-03-01
Completion date
2017-07-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Continuous enteral feeding mode that is aimed at achieving daily caloric target is the standard practice in ICU. However, there is no strong evidence in favour of continuous enteral feeding over intermittent feeding. Continuous feeding infusions are interrupted for nearly 25% of the time and are often delivered at a reduced rate for reasons such as perceived gut intolerance or dysmotility and the need to withhold feeds for concurrent medical, surgical and diagnostic procedures. Consequently, patients in ICU are often underfed. Intermittent enteral feeding is more physiological. It mimics the natural ingestion-fasting cycle and preserves the natural cyclical secretion of gut hormones such as gastrin and motilin. These hormones are closely related to the cycle of meal ingestion and the period of fasting between two meals. It is plausible that continuous feeding interferes with ingestion-fasting cycle and interrupts the natural rhythm of hormonal secretion that is primarily responsible for gastrointestinal motility. Further, intermittent feeding mode is less affected by frequent interruptions, and therefore may also be more effective in achieving daily caloric target. Additionally, there is evidence for more efficient gastric emptying in the right lateral position (J Nucl Med. 1996). Delivering intermittent feeds while in right lateral position seems feasible, as regular posture turns are part of standard nursing care. However, such posture-aided intermittent feeding has not yet been investigated. Aim: To determine whether intermittent enteral feeding during the right lateral tilt position results in less gastrointestinal intolerance compared to standard care among mechanically ventilated patients. Methods: 120 eligible patients who are likely to require mechanical ventilation in ICU for at least 24 hours will be randomly allocated to either standard care arm or intermittent feeding arm. The feeding formulae and target feed volume and continuous infusion rate will be determined prior to randomization. Patients in the intermittent feeding arm will be fed at least three times a day with one third of daily target feed volume infused over one hour each time. Informed consent will be sought from the person responsible or the legal surrogate. Patients will be followed until ICU discharge or maximum 14 days whichever is earlier. Primary end-point: Incidence rate of gastrointestinal intolerance (vomiting, diarrhea or constipation). Secondary end-points: Days free of gastrointestinal intolerance (vomiting, diarrhea or constipation) until day 14, episodes of vomiting and diarrhea per patient, time to vomiting or diarrhea, mean diet volume ratio (diet received/ diet prescribed) expressed as percentage, ventilator-free days until day 14, and all-cause hospital mortality.

Interventions

This study will compare a strategy of intermittent enteral feeding while in right lateral tilt position (intervention) to the current standard practice of continuous enteral feeding (control) among mechanically ventilated patients in ICU. The choice of feeding bag/formulae, ‘target daily feed volume’ and target continuous infusion rate will be determined as per standard practice or at the discretion of the treating clinician. The ‘target daily feed volume’ will be derived as a product of target

This study will compare a strategy of intermittent enteral feeding while in right lateral tilt position (intervention) to the current standard practice of continuous enteral feeding (control) among mechanically ventilated patients in ICU. The choice of feeding bag/formulae, ‘target daily feed volume’ and target continuous infusion rate will be determined as per standard practice or at the discretion of the treating clinician. The ‘target daily feed volume’ will be derived as a product of target continuous infusion rate and the number of hours left in the day (maximum 24 hours). The ‘bolus target’ volume in the intermittent feeding arm will be one-third of the target daily feed volume, and must not exceed 10 ml/kg unless reviewed by the clinician. Patients will have routine posture turns every 3-4 hours as per the standard nursing practice in both arms. The study intervention period is for the duration that a patient require enteral feeding via the gastric feeding tubes while in ICU. Signs of feed intolerance (such as vomiting, oral regurgitation of gastric contents, abdominal pain or tenderness, distension, inability to pass flatus >3 days or abnormal abdominal imaging) and volume of gastric aspirates will be monitored in both arms as per standard practice. If feeding is well tolerated and the gastric aspirate volume is low (<150 ml), then the subsequent feed rate (in the standard arm) or bolus feed volume (in the intermittent arm) should be increased in incremental steps (100 to 150 ml) to gradually achieve the target rate or the target volume. In other words, the subsequent bolus feed volume in the intermittent arm will gradually and incrementally go up only if a patient shows none of the six signs of feed intolerance mentioned above, and has low gastric aspirates (<150 ml). In addition, the protocol is pragmatic and allows clinicians and the unit dietitian to adjust bolus volumes as deemed suitable. The use of pro-kinetic agents will be as per the discretion of the treating clinician in both arms in response to either feed intolerance or large gastric aspirates. The patients in the intervention group will be fed thrice a day with up to one-third of the target feed volume for the day infused within one hour each time. The patients will be nursed in routine semi-recumbent right lateral tilt position (or sitting upright position if out of bed) during the feeding hour and for another two hours post-feeding. The recommended feed times are 5-6 am, 12-1 pm and 8-9 pm, but these timings can be adjusted by the bedside nurse if deemed appropriate. This imply that each day patients in the interventional arm would spend 3 hours thrice a day in right lateral tilt position during feed times and rest of the 15 hours would be spent in supine or left lateral tilt position at the discretion of the bedside nurse. If a patient is being initiated on intermittent enteral feeding for the first time, then the volume of the first feed will be 150 ml, and the subsequent feed volumes will be titrated, in incremental steps until bolus target is attained, according to feed tolerance and volume of gastric aspirates. For all the study patients, gastric tube must be aspirated just before any scheduled upper airway or upper GI procedure. Feeds should restart after the procedure as per the current standard practice if and when there are no medical contraindications. For patients in the intervention group, feed timings can be adjusted at the discretion of the bedside nurse so that the patient do not receive any enteral feeds at least 4 hours before any scheduled upper airway or upper GI procedures.

Sponsors

John Hunter Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026