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
Not Applicable
Completed
- Conditions
- Critical illnessDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12619000106134
- Lead Sponsor
- Melbourne Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
Critically-ill patients admitted to the ICU who:
- require enteral feeding
- are suitable to have a small intestinal feeding catheter inserted
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful rate of insertion of Kangaroo tube with IRIS technology by established users (>= 5 previous attempts). <br>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. [ At time of insertion.]
- Secondary Outcome Measures
Name Time Method Time taken to insert Kangaroo feeding tube with IRIS technology.<br>This will be determined by clinician at the time of insertion using a time-measuring device (i.e. clock). [ At time of successful insertion.];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).<br>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). [ At completion of the study.]