RecruitingNot ApplicableNCT06382727

CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care

CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care: a Pilot Randomised Controlled Trial (CONTINUE Trial)


Sponsor

Emma Ridley

Enrollment

60 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally. The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation). The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN. This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • years or older
  • Receiving invasive mechanical ventilation > 24 hours and < 10 days in the index ICU admission
  • Receiving EN at a rate ≥ 30ml/hr
  • Planned for extubation within the hours of 0800-1800

Exclusion Criteria10

  • EN delivery via a fine bore nasogastric tube that is unable to be aspirated
  • A single gastric residual volume ≥ the maximum protocol limit at the participating site has been recorded within the last 24 hours
  • Currently receiving extracorporeal membrane oxygenation
  • Acute neurological pathology
  • A time critical medication is required via the enteral route (including anti-parkinsons and immunosuppressant medication) and no adjustments can be made
  • Pre-existing swallow, bulbar dysfunction and/or concern around inadequate airway protection
  • A laparotomy has been performed within 72 hours of planned extubation
  • Confirmed pregnancy
  • Patient not deemed appropriate to be reintubated in the event of deterioration
  • Treating clinician believes enrolment is not in the best interests of the patient

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Interventions

OTHEREN will be continued up to extubation (EN will not be withheld prior to extubation)

As per the arm/group descriptions.


Locations(3)

Gold Coast University Hospital

Southport, Queensland, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

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NCT06382727


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