A Novel Device for Accurate Chest Tube Insertion: A Randomized Controlled Trial
2016
Background Optimal positioning of a large-bore
chest tubeis in the part of the
pleural cavitythat needs drainage. It is recommended that the
chest tubebe positioned apically in
pneumothoraxand basally for fluids. However, targeted
chest tubepositioning to a specific part of the
pleural cavitycan 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
pneumothoraxwas apical (above the aortic arch), and the optimal position in
hemothorax,
hydrothorax,
chylothorax, or
empyemawas 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 tubeswere optimally position in 41 (84%) in the KatGuide group vs 32 (53%) in the conventional group ( p = 0.001). Experienced operators (>50 previous
chest tubeinsertions) 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 tubeposition and reduces the risk of misplacement compared with the conventional method. ClinicalTrial.gov
Trial RegistrationNumber: NCT01522885.
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