Intraoperative inhalation of indocyanine green for detection of air leak sites after lung resection: study protocol for a randomized controlled trial

Abstract Background Postoperative air leak is a common complication after pulmonary surgery. Intraoperative identification and repairing of all air leaks are essential to prevent this complication. However, the traditional saline submersion test would cause oversight of some air leak sites because of the limited field of view in video-assisted thoracoscopic surgery (VATS), especially in patients with pleural adhesions. This trial aims to evaluate the efficacy of indocyanine green inhalation for intraoperative detection of air leaks during VATS. Methods This multi-center, two-arm, prospective, randomized controlled, parallel group trial is designed to compare intraoperative indocyanine green (ICG) inhalation and saline submersion test in terms of identifying intraoperative air leak sites and reducing postoperative air leak. This trial will include 460 patients who will underwent VATS lung resection with a 1:1 randomization. The primary outcomes are the immediate postoperative air leak rate and the number and size of air leak sites during surgery. the secondary outcomes are time of detection, time of intraoperative repair, duration of chest tube, duration of postoperative air leak and the prolonged air leak rate. Discussion The method for intraoperative detection of air leaks has remained unchanged for decades, which is constrained by the limited surgical field visibility in patients underwent VATS. Therefore, a novel technique without such limitation is meaningful for preventing oversight of the air leak sites. We hope the result of this study will provide valuable information on the clinical benefit of this novel approach for air leak detection. Trial registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400080627. Registered on 2 February 2024. Trial registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400080627 . Registered on 2 February 2024.