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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
Scientific title
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care: A Pilot Randomised Controlled Trial (CONTINUE Trial)
Secondary ID [1] 0 0
ER008
Universal Trial Number (UTN)
Trial acronym
CONTINUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting time (hours)
Timepoint [1] 0 0
24 hours prior to endotracheal tube removal
Secondary outcome [1] 0 0
Reintubation rate
Timepoint [1] 0 0
48 hours post endotracheal tube removal
Secondary outcome [2] 0 0
Days alive and free of mechanical ventilation
Timepoint [2] 0 0
Up to day 28 post randomisation
Secondary outcome [3] 0 0
Commencement of antibiotics
Timepoint [3] 0 0
Up to 7 days post endotracheal tube removal
Secondary outcome [4] 0 0
Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2)
Timepoint [4] 0 0
12 hours post endotracheal tube removal
Secondary outcome [5] 0 0
ICU length of stay
Timepoint [5] 0 0
Up to day 28 post randomisation
Secondary outcome [6] 0 0
In-hospital mortality
Timepoint [6] 0 0
Up to day 28 post randomisation
Secondary outcome [7] 0 0
Nutrition delivery
Timepoint [7] 0 0
24 hours prior to endotracheal tube removal
Secondary outcome [8] 0 0
Recruitment rate
Timepoint [8] 0 0
Up to the end of the study period
Secondary outcome [9] 0 0
Protocol compliance
Timepoint [9] 0 0
Up to Endotracheal Tube removal

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Emma Ridley
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emma Ridley, A/Prof
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0350
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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