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Trial registered on ANZCTR


Registration number
ACTRN12606000367549
Ethics application status
Not yet submitted
Date submitted
16/08/2006
Date registered
22/08/2006
Date last updated
22/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients.
Scientific title
A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enteral feeding of ventilated critically ill patients 1336 0
Condition category
Condition code
Oral and Gastrointestinal 1424 1424 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once entered into the study, patients will be randomised to either enteral feeding via the stomach using a nasogastric tube, or post pyloric via a smaller, Corflo tube.

The tube will be inserted using a standard technique

Patients in the post-pyloric group will also receive a gastric tube to allow for aspiration of stomach contents

If a post-pyloric tube cannot be inserted, a gastric tube will be placed and the patient fed according to our standard protocol

Once placed, feeds will be initiated immediately. The current ICU feeding protocol will be used to escalate feeds to target

The nutritional requirements for each patient will be calculated using a standard formula

Patients will remain in the study until they are able to eat or are discharged from ICU
Intervention code [1] 1311 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1946 0
TIme from initiation of feeds to time at which goal feeds are reached.
Timepoint [1] 1946 0
Primary outcome [2] 1947 0
Total calorie intake during intensive care admission.
Timepoint [2] 1947 0
Secondary outcome [1] 3407 0
Complications associated with small bowel feeding.
Timepoint [1] 3407 0
Secondary outcome [2] 3408 0
Number of days in Intensive care.
Timepoint [2] 3408 0
Secondary outcome [3] 3409 0
Number of days requiring mechanical ventilation days.
Timepoint [3] 3409 0

Eligibility
Key inclusion criteria
All critically ill patients admitted to intensive care expected to require at least 24 hours of mechanical ventilation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ischaemic bowel, bowel obstruction, severe exacerbation of inflammatory bowel disease, acute variceal bleeding and patients deemed high risk for anastamotic leaks by the surgeons.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are blinded
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1556 0
Self funded/Unfunded
Name [1] 1556 0
Country [1] 1556 0
Primary sponsor type
Individual
Name
Hayden White
Address
Country
Secondary sponsor category [1] 1369 0
Individual
Name [1] 1369 0
Kellie Sosnowski
Address [1] 1369 0
Country [1] 1369 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Early enteral feeding is recognised as an important contributor to patient outcome in critically ill patients. This goal can be hard to achieve as patient often have difficulty tolerating nasogastric feeds. This is due to the tendency for seriously ill patients to develop a gastric ileus. One option is to begin intravenous feeding. However, parentral feeding is expensive and associated with a number of complications including sepsis.
The insertion of post-pyloric tubes has been advocated for a number of years to overcome the problems with gastric feeding. Unfortunately, these tubes are difficult to place blindly, often requiring the assistance of gastroenterologists or radiologists. This often leads to delays instituting feeds, negating the benefits of early feeding. A number of centres have described protocols for placing small bowel tubes but with limited success.
Recently, a simple technique with a relatively high success rate was described by a group of researchers. Our ICU has adopted their protocol and over the past few months have noted a success rate of nearly 100%. The implications are that by using this method, we are able to entrally feed virtually all our patients from day one.
The aim of our study is to compare gastric and post-pyloric feeding in ventilated, critically ill patients. Our primary end-points include: time to insertion of feeding tube, time to reaching goal feeds and total nutrition received over ICU stay as proportion of calculated ideal. As part of the analysis we intend to compare complication rates between groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27918 0
Address 27918 0
Country 27918 0
Phone 27918 0
Fax 27918 0
Email 27918 0
Contact person for public queries
Name 10500 0
Hayden White
Address 10500 0
Intensive Care Unit
Logan Hospital
Cnr Armstrong & Loganlea Roads MEADOWBROOK QLD 4133
Country 10500 0
Australia
Phone 10500 0
32998899
Fax 10500 0
Email 10500 0
[email protected]
Contact person for scientific queries
Name 1428 0
Hayden White
Address 1428 0
Intensive Care Unit
Logan Hospital
Cnr Armstrong & Loganlea Roads MEADOWBROOK Qld 4133
Country 1428 0
Australia
Phone 1428 0
32998899
Fax 1428 0
Email 1428 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.