AzTrials
AzTrials

Critical IllnessCONTINUENCT06382727

CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care

A study testing EN will be continued up to extubation (EN will not be withheld prior to extubation) in people with Critical Illness, run by Emma Ridley at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
EN will be continued up to extubation (EN will not be withheld prior to extubation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesAustralia
Study dates
20 May 2024to 28 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Australia3 sites
  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Gold Coast University Hospital

    Southport, Queensland, 4215

Other trials in Australia

About this study

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

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).

Read more

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.

Read the detailed description

The provision of EN is standard practice to mechanically ventilated patients within the ICU. Delivery is frequently interrupted, with patients often receiving approximately half of prescribed volumes. One of the main contributors to this is fasting prior to extubation. Fasting prior to extubation is historically informed from pre-anaesthetic practice in patients who are not critically ill where fasting allows for adequate gastric emptying and reduces the risk of aspiration on induction. The practice of fasting prior to extubation is less informed, and variable. A recent scoping review identified only 1 randomised controlled trial (RCT) and 13 observational studies on this topic. The review found fasting durations varied between 0-34 hours and the reasons for fasting prior to extubation were safety related; however, these reasons were often extrapolated from data outside of the ICU as outlined above. The review concluded that there is an evidence gap and no evidence-based consensus as to the rationale and duration of fasting critically ill patients prior to extubation.

The clinical consequences of fasting (and particularly repeated fasting) are not well understood; however, it is known that fasting leads to reduced nutrition which may negatively impact response to illness, particularly in patients with a long length of stay. Beyond this, the requirement for fasting may delay extubation and progression of care (as extubation may be cancelled if the patient is not adequately fasted) and lead to unnecessary use for nursing and medical resources.

The CONTINUE trial represents the first trial of its kind in Australia and seeks to determine feasibility to inform a program of research that addresses a universal practice for critically ill patients requiring mechanical ventilation. Establishment of feasibility will provide data to inform a large RCT of similar nature, powered to determine differences in important clinical outcomes such as reintubation rate, ventilator free days to day 28 of admission and development of aspiration pneumonia. The culmination of this research will be to create an evidence-based guideline on pre-extubation fasting with the aim of standardising and informing international practice.

The primary aim is to determine whether continuing EN to the point of extubation and performing maximal nasogastric aspiration immediately prior is feasible and decreases total fasting in the time 24 hours prior to extubation compared to standard practice of ceasing EN 4- 6 hours prior to planned extubation, in low risk ventilated patients. Secondary objectives include assessment of important safety related endpoints including change in oxygenation requirements, aspiration, reintubation rate at 48 hours after extubation and clinical outcome measures including ICU and hospital morbidity and mortality.

Being tested
EN will be continued up to extubation (EN will not be withheld prior to extubation)
Keywords
Extubation, Enteral Nutrition, Fasting
Medical subject headings
Critical Illness, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    As per the arm/group descriptions.

Study groups in NCT06382727
Study groupRoleWhat they receive
Intervention group: Continuation of enteral nutrition (EN) prior to extubationExperimentalMaintenance of EN at the same hourly rate until the point of extubation. Maximal suction of the EN tube prior to extubation will take place.
Receives: Other: EN will be continued up to extubation (EN will not be withheld prior to extubation)
Control group: Cessation of EN prior to extubationNo interventionCessation 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting time (hours)

    Fasting time due to planned extubation

    Measured: 24 hours prior to endotracheal tube removal

Secondary outcomes (9)
  1. Reintubation rate

    Actual reintubation rate and according to an objective criterion for failure:

    Respiratory acidosis (pH <7.35 with Paco2 >45 mm Hg); Spo2 less than 90% or Pao2 less than 60 mm Hg at Fio2 greater than 0.4; Respiratory rate greater than 35/min; Decreased level of consciousness (defined as a decrease in GCS score >1 point); Agitation, or clinical signs suggestive of respiratory muscle fatigue, increased work of breathing (eg, the use of respiratory accessory muscles, paradoxical abdominal motion, or retraction of the intercostal spaces), or both; Patients dying within 72 hours will also be considered as extubation failures.

    Measured: 48 hours post endotracheal tube removal

  2. Days alive and free of mechanical ventilation

    Number of days alive and free of mechanical ventilation

    Measured: Up to day 28 post randomisation

  3. Commencement of antibiotics

    Commencement of antibiotics for a chest infection or aspiration

    Measured: Up to 7 days post endotracheal tube removal

  4. Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2)

    SpO2:FiO2 ratio

    Measured: 12 hours post endotracheal tube removal

  5. ICU length of stay

    ICU length of stay (days)

    Measured: Up to day 28 post randomisation

  6. In-hospital mortality

    In-hospital mortality during ICU or acute ward admission

    Measured: Up to day 28 post randomisation

  7. Nutrition delivery

    The absolute and relative (to calculated requirements) amount of calories delivered

    Measured: 24 hours prior to endotracheal tube removal

  8. Recruitment rate

    Number of patients recruited per month

    Measured: Up to the end of the study period

  9. Protocol compliance

    Defined as the proportion of patients receiving the allocated intervention

    Measured: Up to Endotracheal Tube removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start20 May 2024
  3. Primary completion15 Apr 2025
  4. Study completion28 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382727
Sponsor's protocol ID
ANZIC- RC ER008
Acronym
CONTINUE
Status last verified
May 2026
First submitted
15 Apr 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36115335

Questions about this trial

What is this clinical trial studying?

A study testing EN will be continued up to extubation (EN will not be withheld prior to extubation) in people with Critical Illness, run by Emma Ridley at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting time (hours) (time frame: 24 hours prior to endotracheal tube removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in