Matthew D Burstein, MD, PhD, Kevin El-Hayek, MD. Cleveland Clinic Foundation
Objective of the device: Overinflation of a jejunostomy tube balloon occurs at a significant rate based on our experience with clinical tube dysfunction and incidental discovery on abdominal imaging during admission or hospital transfers. Additionally, there is a potential for iatrogenic injury when tube feeds or medications are erroneously inserted into the balloon port. Standard tube gastrostomy / jejunostomy balloons can hold over 35 ccs – well over safe volume for the narrow lumen of the small bowel. We witnessed three separate events, one of which resulted in bowel obstruction, prompting institutional root cause analysis, as well as implementation of a novel mechanical barrier and protocol to prevent future events.
Description of the technology and method of its application: A flexible polymer cap was designed with two goals. The cap had to universally fit all stocked gastrostomy / jejunostomy tubes sized between 12FR and 20FR with balloons. Additionally the cap had to be reasonably tamper proof following installation. A protocol was developed to interrogate jejunostomy tube balloons on hospital transfer and to lock the balloon port at a volume of 3 ccs. A pilot of this protocol was performed immediately after jejunostomy tubes were inserted by our minimally invasive surgery service.
Preliminary results: Ten patients had 3D-printed prototypes of the balloon port cap applied after 3 cc water injection. The cap fit securely and locked as designed. There were no events related to the installation of the caps and they were well tolerated.
Future directions: Clinically significant balloon overinflation events are rare but potentially life threatening and can result in missed medication and additional procedures. This includes tube exchange, endoscopy, and even laparotomy. We suspect that the baseline subclinical overinflation of jejunostomy balloons occurs at an appreciable rate. Rather than relying on provider education alone, we opted to develop and protocolize a method to prevent all overinflation events. The described locking cap functions as designed and will be utilized post-procedurally and also on hospital transfers with jejunostomy tubes. Modification or finalization of the cap is dependent on widespread patient and provider feedback.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 98836
Program Number: ETP765
Presentation Session: Emerging Technology Poster Session (Non CME)
Presentation Type: Poster