Single‐Stage Tympanosotomy Tube Insertion: Design Issues on a New Surgical Approach

Abstract

Objectives: Multiple efforts are under way to develop methodologies to allow tympanostomy tube (TT) placement in young children under conscious sedation where there can be significant head motion. This practice modification would provide an option for TT placement without the risk of general anesthesia and the potential for procedures being performed in an office. Methods: Investigators evaluated a tool designed to perform a quick, single pass tube delivery across the tympanic membrane with a downward force of motion in a moving child under conscious sedation. Training required bench evaluation and the use of general anesthesia before performing conscious sedation cases. Results: A total of 176 TTs were performed in 89 children at 3 institutions. Ninety-one TTs in 46 children used general anesthesia, and 85 TTs in 43 children used conscious sedation. Conscious sedation included nitrous oxide in 35 children and midazolam plus nitrous oxide in 8 patients. All cases used phenol as a topical anesthetic. Twelve children were converted to general anesthesia for over-insertions, design challenges, anatomy, or movement. The major complication encountered was delivery of the TT into the middle ear space. Multiple tubes were used, but a beveled medial flange tube with a lateral visualization tab to provide depth feedback proved most effective for attenuating patient movement without TT over-insertion (64 children). Conclusions: Early results show that TT placement in children may be done safely under conscious sedation. Additional clinical experience is required to optimize the tool and the training to prevent complications of TT placement with a single-pass device.