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Prospective first-time study of the Eustachian tube catheter Tuba Clean® applied during middle ear surgical proceduresSpiggle & Theis Medizintechnik GmbH
18 April 2018 (online)
The main objective of the study was to analyze the clinical practicability and patients safety of the Tuba clean™ catheter for probing and flushing the Eustachian tube (ET) during middle ear operations.
The prospective, first-time monocentric study was based on a questionnaire completed by the surgeon after 50 tympanoplasties between 11/16 and 08/17. The procedures could be divided into tympanoplasties Typ I (n = 23), IIIa (n = 14), IIIb (n = 7), IIIc (n = 3) and tympanoscopies (n = 3).
The study confirmed that the guide wire inside the catheter was helpful to insert the catheter tip straight into the tympanic tube orifice. In 14 cases the insertion of the catheter was directly performed through the preexisting tympanic membrane defect. In 4 cases an endoscope was applied to visualize the tube orifice. In 42 cases the lateral attic bone had to be reduced for a better view on the tubal region. Even in cases with an intact ossicular chain the probing of the ET can be managed with the help of an endoscope or even – after slightly bending the catheter tip – blindly under digital control without any direct view of the ET orifice. Due to the atraumatic knobby catheter tip no mucosal damage (e.g. bleeding) occurred. If the insertion of the catheter stops at the curved bony isthmus region after 15 mm a stepwise withdrawal of the guide wire made further insertion possible (n = 11) without tip fold over (endoscopic control in nasopharynx). In 44/50 (88%) of the cases probing and flushing with sterile saline solution was possible. No complications occurred.
The Tuba clean™ is a simple and safe device providing ear surgeons with a technique of diagnostic probing and cleaning of the ET with regard to bone dust or in cases of a glue tube.