CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care

NCT06382727 | Completed

• 1 other identifier: ANZIC- RC ER008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Critical Illness

Keywords

Extubation; Enteral Nutrition; Fasting

Outcome Measures

Primary Outcomes (1)

• Fasting time (hours)

  Fasting time due to planned extubation

  24 hours prior to endotracheal tube removal

Secondary Outcomes (9)

• Reintubation rate

  48 hours post endotracheal tube removal

• Days alive and free of mechanical ventilation

  Up to day 28 post randomisation

• Commencement of antibiotics

  Up to 7 days post endotracheal tube removal

• Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2)

  12 hours post endotracheal tube removal

• ICU length of stay

  Up to day 28 post randomisation

Study Arms (2)

Intervention group: Continuation of enteral nutrition (EN) prior to extubation

EXPERIMENTAL

Maintenance of EN at the same hourly rate until the point of extubation. Maximal suction of the EN tube prior to extubation will take place.

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

Control group: Cessation of EN prior to extubation

NO INTERVENTION

Cessation of EN at least 4-6 hours prior to the point of extubation. Maximal suction of the EN tube prior to extubation will take place.

Interventions

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

As per the arm/group descriptions.

Intervention group: Continuation of enteral nutrition (EN) prior to extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emma Ridley: lead

Study Sites (3)

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Varghese JA, Tatucu-Babet OA, Miller E, Lambell K, Deane AM, Burrell AJC, Ridley EJ. Fasting practices of enteral nutrition delivery for airway procedures in critically ill adult patients: A scoping review. J Crit Care. 2022 Dec;72:154144. doi: 10.1016/j.jcrc.2022.154144. Epub 2022 Sep 15.

  PMID: 36115335 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Fasting

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A/Prof

Model Details: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: May 20, 2024
• Primary Completion: April 15, 2025
• Study Completion: August 28, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

AU (3)