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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06382727
Registration number
NCT06382727
Ethics application status
Date submitted
15/04/2024
Date registered
24/04/2024
Titles & IDs
Public title
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care
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Scientific title
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care: A Pilot Randomised Controlled Trial (CONTINUE Trial)
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Secondary ID [1]
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ER008
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Universal Trial Number (UTN)
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Trial acronym
CONTINUE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - EN will be continued up to extubation (EN will not be withheld prior to extubation)
Experimental: Intervention group: Continuation of enteral nutrition (EN) prior to extubation - 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.
No intervention: Control group: Cessation of EN prior to extubation - 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.
Other interventions: EN will be continued up to extubation (EN will not be withheld prior to extubation)
As per the arm/group descriptions.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Fasting time (hours)
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Assessment method [1]
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Fasting time due to planned extubation
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Timepoint [1]
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24 hours prior to endotracheal tube removal
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Secondary outcome [1]
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Reintubation rate
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Assessment method [1]
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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.
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Timepoint [1]
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48 hours post endotracheal tube removal
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Secondary outcome [2]
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Days alive and free of mechanical ventilation
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Assessment method [2]
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Number of days alive and free of mechanical ventilation
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Timepoint [2]
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Up to day 28 post randomisation
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Secondary outcome [3]
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Commencement of antibiotics
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Assessment method [3]
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Commencement of antibiotics for a chest infection or aspiration
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Timepoint [3]
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Up to 7 days post endotracheal tube removal
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Secondary outcome [4]
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Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2)
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Assessment method [4]
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SpO2:FiO2 ratio
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Timepoint [4]
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12 hours post endotracheal tube removal
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Secondary outcome [5]
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ICU length of stay
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Assessment method [5]
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ICU length of stay (days)
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Timepoint [5]
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Up to day 28 post randomisation
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Secondary outcome [6]
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In-hospital mortality
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Assessment method [6]
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In-hospital mortality during ICU or acute ward admission
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Timepoint [6]
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Up to day 28 post randomisation
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Secondary outcome [7]
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Nutrition delivery
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Assessment method [7]
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The absolute and relative (to calculated requirements) amount of calories delivered
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Timepoint [7]
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24 hours prior to endotracheal tube removal
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Secondary outcome [8]
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Recruitment rate
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Assessment method [8]
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Number of patients recruited per month
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Timepoint [8]
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Up to the end of the study period
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Secondary outcome [9]
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Protocol compliance
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Assessment method [9]
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Defined as the proportion of patients receiving the allocated intervention
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Timepoint [9]
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Up to Endotracheal Tube removal
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Emma Ridley
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06382727
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Emma Ridley, A/Prof
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Address
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Country
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Phone
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+61 3 9903 0350
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06382727