Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000106134
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
24/01/2019
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an enhanced feeding tube with integrated visualisation technology in the placement of small intestinal tubes in critically ill patients: A prospective multicenter international cohort study
Scientific title
Evaluation of the enhanced Kangaroo feeding tube with Integrated Real-time Imaging System (IRIS) technology for post-pyloric placement in critically ill patients: A prospective multicenter international cohort study.
Secondary ID [1] 297089 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 311102 0
Condition category
Condition code
Diet and Nutrition 309733 309733 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Kangaroo feeding tube with IRIS technology placed post-pylorically in critically ill patients. In the ICU, as per standard care patients are assessed to determine whether there is a clinical requirement for post-pyloric feeding. To facilitate this, standard care dictates that a small feeding tube (i.e the Kangaroo feeding tube with IRIS technology), be inserted in the small intestine. This may be clinically indicated for a number of reasons, including large gastric residual volumes and decreased gastric motility.

This study will be observing the success rate of the Kangaroo feeding tube with IRIS technology insertion, and no intervention outside of standard care will be carried out.

The tube will be inserted by an ICU clinician once in each participant, and will remain in place as long as a post-pyloric feeding tube is clinically indicated in the participant. Once removed, the tube will only be reinserted if required in the opinion of the treating clinican. Study observation will only occur during insertion of the feeding tube (typically 30 minutes to one hour).

The Kangaroo feeding tube with IRIS technology has a 3mm camera integrated within the tip that transmits images to a visual display. The picture quality is similar to the resolution obtained with the iPhone camera. The tube is single use, disposable, and has TGA approval for the intended purpose of ‘administration of nutrition, fluids and medications for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition'.

The device has the potential to be superior to both the ‘blind’ placement of gastric tubes, and the endoscopic placement approach to post-pyloric tube insertion because it may facilitate more rapid placement, and the visualisation feature may diagnose certain occult gastrointestinal pathologies (e.g. ulceration), with fewer contraindications. Furthermore, direct visualisation of duodenal placement may eventually obviate the need for radiological confirmation (abdominal x-ray ~0.7mSv) as is current practice not only with 'blind' placement of gastric tubes but also endoscopically placed small intestinal catheter tubes.
Intervention code [1] 313364 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318697 0
Successful rate of insertion of Kangaroo tube with IRIS technology by established users (>= 5 previous attempts).
This will be determined by clinician at the time of insertion. An abdominal x-ray will only be performed to confirm insertion if required in the clinician's opinion. A de-identified image of the lumen will also be taken at the completion of insertion. This will be stored, encrypted, and reviewed in block by an experienced endoscopist who will confirm successful insertion.
Timepoint [1] 318697 0
At time of insertion.
Secondary outcome [1] 365754 0
Time taken to insert Kangaroo feeding tube with IRIS technology.
This will be determined by clinician at the time of insertion using a time-measuring device (i.e. clock).
Timepoint [1] 365754 0
At time of successful insertion.
Secondary outcome [2] 365756 0
Evaluation of whether there is a 'learning curve' associated with using the device (comparing intra-individual success of the first 4 insertion attempts to subsequent attempts).
Successful insertion will be confirmed by clinician at the time of insertion (abdominal x-ray confirmation only performed if required in the opinion of clinician), as well as by experienced endoscopist (using encrypted, de-identified images of participants lumen, sent in block). The success of each individuals first 4 insertion attempts will then be compared to the success of their subsequent attempts, to determine whether a 'learning curve' exists (i.e. operators progressively attaining a higher proportion of successful attempts at insertion as they gain experience).
Timepoint [2] 365756 0
At completion of the study.

Eligibility
Key inclusion criteria
Critically-ill patients admitted to the ICU who:
- require enteral feeding
- are suitable to have a small intestinal feeding catheter inserted
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In the opinion of the treating clinician, there is a medical condition or concern that means that the patient would not be suitable for a post-pyloric tube, or there is a contraindication to post-pyloric tube placement.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis
We will collect usage for all insertions. The first four insertions will be considered the 'learning phase'. Data for insertion 5 and onward will be used toward the primary outcome, but we will compare success in experienced users to their success in the 'learning phase'. Data from 15 insertions at 5 centres will provide us with a reasonable evaluation of this technique.

We will summarise data using descriptive statistics and include frequency (95% confidence intervals) and time taken (median [IQR]).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 12923 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 12924 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25398 0
3050 - Parkville
Recruitment postcode(s) [2] 25399 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 21203 0
United States of America
State/province [1] 21203 0
Missouri
Country [2] 21204 0
United States of America
State/province [2] 21204 0
North Carolina
Country [3] 21205 0
Panama
State/province [3] 21205 0
Panama City

Funding & Sponsors
Funding source category [1] 301655 0
Commercial sector/Industry
Name [1] 301655 0
Cardinal Health
Country [1] 301655 0
United States of America
Primary sponsor type
Hospital
Name
Melbourne Health
Address
The Royal Melbourne Hospital
300 Grattan Street,
Parkville 3050
Victoria
Country
Australia
Secondary sponsor category [1] 301367 0
None
Name [1] 301367 0
N/A
Address [1] 301367 0
N/A
Country [1] 301367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302376 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 302376 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street, Parkville 3050
VICTORIA, Australia
Ethics committee country [1] 302376 0
Australia
Date submitted for ethics approval [1] 302376 0
Approval date [1] 302376 0
20/12/2018
Ethics approval number [1] 302376 0
HREC/18/MH/271

Summary
Brief summary
Nutritional therapy is a vital component of standard care in critically ill patients, with nasogastric tubes being the preferred route of administration. Despite this, approximately 50% of patients fail to meet their caloric targets, potentially leading to adverse effects on clinical outcomes. Unsuccessful nasogastric feeding in the critically ill has many possible causes, but primary reflects delayed gastric emptying. As small-bowel motility remains relatively preserved, direct nutrient delivery into the duodenum may increase caloric intake. Furthermore, post-pyloric feeding may decrease the frequency of ventilator-associated pneumonia. However, inserting a post-pyloric feeding tube can be technically challenging, expensive, and requires a gastroenterologist which is not routinely available in the ICU.

The Kangaroo feeding tube with IRIS technology has been specially designed to facilitate the insertion of feeding tubes post-pylorically by allowing clinicians to visualise insertion and duodenal placement. This visualisation feature may diagnose certain occult gastointestinal pathologies and obviate the need for radiological confirmation (abdominal x-ray), as is current practice.

This prospective multicenter international cohort study will evaluate the success of this device in post-pyloric feeding tube insertion in critically ill patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90014 0
A/Prof Adam Deane
Address 90014 0
Level 5, Building B
The Royal Melbourne Hospital
300 Grattan Street, Parkville
Victoria 3050
Country 90014 0
Australia
Phone 90014 0
+61 3 9342 9254
Fax 90014 0
Email 90014 0
[email protected]
Contact person for public queries
Name 90015 0
Ms Deborah Barge
Address 90015 0
Level 5, Building B
The Royal Melbourne Hospital
300 Grattan Street, Parkville
Victoria 3050
Country 90015 0
Australia
Phone 90015 0
+61 3 9342 9235
Fax 90015 0
Email 90015 0
[email protected]
Contact person for scientific queries
Name 90016 0
A/Prof Adam Deane
Address 90016 0
Level 5, Building B
The Royal Melbourne Hospital
300 Grattan Street, Parkville
Victoria 3050
Country 90016 0
Australia
Phone 90016 0
+61 3 9342 9254
Fax 90016 0
Email 90016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage, no IPD will be available.


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.