Syncro Medical Innovations, Inc. was founded in Macon, Georgia in 1998. The first generation feeding tube (Magnaflow) utilized a hand held external magnet to steer the feeding tube into the distal duodenum. The feeding tube had a small magnet embedded at its distal end. The second generation feeding tube was enhanced by the addition of a magnetically activated sensor switch near the tube’s distal end and a light indicator at the proximal end. The third generation feeding tube (Syncro Blue Tube) was improved by re-locating the tube distal end magnets to the removable stylet.
Now in its fourth generation, the Gabriel® Feeding Tube with Balloon incorporates a small balloon at the tube’s distal end that allows the tube to advance post-pyloric via peristalsis. This eliminates the need for the external steering magnet and the tube's distal end magnet. Inflation of the balloon at mid-esophagus provides confirmation that the tube is inserted in the esophagus, not in the trachea, by observing no decline in pulse oximetry within 2 minutes.
The Gabriel Feeding Tube with Balloon and EnFit connector, fifth generation, is provided with a CO2 sampling line that detects misplacement in the trachea within seconds by observing absence of CO2 waves on the monitor. As in the 4th generation, the inflated distal end balloon prevents inadvertent advancement of the tube into smaller bronchioles and pneumothorax.
The distal end balloon facilitates distal migration into the small intestine to a postpyloric location, by effect of peristalsis on the tube distal end balloon similar to a bolus of food.
Development supported by : NIH-NIDDK grant #1 R44 DK60268
The Gabriel Feeding Tube with Balloon is available with ENFit® connector that is compliant with ISO 80963-3 standard. A convenience kit is provided with all needed accessories.
Gabriel® Feeding Tube with Balloon – New Critical Care Catheter
Development supported by:
DOD Award# W81XWH-09-2-0097
Identified problem:
Enteral feeding tubes historically have been associated with rare but serious complications. Feeding tube misplacement in the lung, although rare (2%), is associated with pneumothorax in 50% of misplaced tubes. An ideal feeding tube should minimize tracheal misplacement and allow early gastric feeding with high potential for post-pyloric migration. The Gabriel Feeding Tube with Balloon (GFTB) was developed by Dr. Sabry Gabriel with support from the United States Department of Defense building on work funded by the NIH to accomplish these goals.
Developed solution:
The GFTB has a balloon at its distal end. It is inserted through the patient’s topically anesthetized nostril. At the 30 cm depth mark (mid-esophagus), the balloon is inflated (using the syringe provided). If no CO2 waveform is observed and the patient’s pulse oximetry does not drop, esophageal placement, rather than lung or tracheal placement, is confirmed within a few seconds. The tube is then advanced to the 70 cm mark, and the stiffening stylet is pulled out gradually as you advance more of the tube to the 100 cm mark. The stylet is removed and the tube is secured at the nose. The tube’s distal end balloon is deflated after 48 hours.
The tube wall is thin and flexible, but does not occlude by kinking, as it is reinforced with a spiral wire. This feature allows for placement of ample slack of the tube in the stomach and feeding without occlusion by kinking. Tube distal migration occurs by the natural effect of peristalsis on the bolus-sized balloon. The tube is packaged with a “convenience kit” that includes a CO2 sampling line, numbing gel, applicator for the numbing gel, lubricant gel, a silk suture thread, syringe, skin adhesive and securing tape to save time during bedside placement.
Clinical validation:
In a published clinical study, no undetected misplacement of a tube in the lung or trachea and no pneumothorax occurred. This is a function of the effectiveness of the balloon as an early detection feature using the CO2 sampling line and patient’s pulse oximetry. Enteral feeding began immediately with the head of bed elevated 30 degrees once gastric placement was confirmed by X-ray. 70% of tubes placed in patients migrated post-pyloric within 12 to 24 hours by the effect of peristalsis on the balloon at the tube’s distal end. It was observed that any nurse who can place an NG tube can easily place the GTFB with little (or no) additional training.
Benefits of enteral feeding are generally well known among clinicians. Whenever possible, post-pyloric feeding can provide an added advantage of reduced gastro-esophageal reflux aspiration pneumonia. In that regard, the Gabriel Feeding Tube with Balloon offers more chance for distal tube migration than tubes without a balloon. It can also be used for gastric feeding with higher likelihood of post pyloric migration than other feeding tubes. The Gabriel Feeding Tube will not occlude by kinking due to the spiral wire reinforced wall. No pneumothorax occurred by using the Gabriel Feeding Tube with Balloon.
Reimbursement: CPT code 43761.