A Novel Device for Accurate Chest Tube Insertion: A Randomized Controlled Trial

BACKGROUND: Optimal positioning of a large-bore chest tube is in the part of the pleural cavity that needs drainage. It is recommended that the chest tube be positioned apically in pneumothorax and basally for fluids. However, targeted chest tube positioning to a specific part of the pleural cavity can be a challenge.

METHODS: A new medical device, the KatGuide, was developed for accurate guiding of a chest tube (28F) to an intended part of the pleural cavity. The primary end point of this randomized, controlled trial was optimal position of the chest tube. The optimal position in pneumothorax was apical (above the aortic arch), and the optimal position in hemothorax, hydrothorax, chylothorax, or empyema was basal (2 cm above the diaphragm or lower). The patients were randomized for the KatGuide method or the conventional forceps method, and rates of optimal position were compared.

RESULTS: A total of 109 patients were enrolled (KatGuide: n = 49; conventional: n = 60). Chest tubes were optimally position in 41 (84%) in the KatGuide group vs 32 (53%) in the conventional group (p = 0.001). Experienced operators (>50 previous chest tube insertions) inserted 39 of the chest tubes, of which, 15 of 17 (88%) were optimally positioned in the KatGuide group vs 11 of 22 (50%) in the conventional group (p = 0.02). Two chest tubes (4%) were misplaced in the KatGuide group vs 11 (18%) in the conventional group (p = 0.04). No adverse device effects were observed.

CONCLUSIONS: The KatGuide significantly improves the probability of optimal chest tube position and reduces the risk of misplacement compared with the conventional method. ClinicalTrial.gov Trial Registration Number: NCT01522885.