Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06382727




Registration number
NCT06382727
Ethics application status
Date submitted
15/04/2024
Date registered
24/04/2024
Date last updated
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
Health Services Research
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2024
Actual
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06382727
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.
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
emma.ridley@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06382727