Abstract
BackgroundThere are increasing studies showing that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery; however, the appropriate positive end-expiratory pressure (PEEP) has not yet defined. Adopting a suitable PEEP may prevent postoperative pulmonary complications. Robot-assisted laparoscopic surgery is the newest and most minimally invasive treatment for bladder cancer or prostate cancer. It is also necessary to consider the effects of Trendelenburg position with pneumoperitoneum on airway pressure and pulmonary function. The role of PEEP during the intraoperative period in preventing postoperative pulmonary complications for robot-assisted laparoscopic surgery is not clearly defined.Methods/designA total of 208 patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer will be enrolled and then randomly assigned to a standard PEEP (6–8 cm H2O) group and a low PEEP (≤2 cm H2O) group. Both groups will receive an inspired oxygen fraction of 0.50 and a tidal volume of 8 mL/kg ideal body weight. Standard perioperative fluid management standardization and analgesic treatments will be applied in both groups. The primary endpoint is postoperative pulmonary complications within 7 days after surgery. Secondary endpoints are the modified clinical pulmonary infection score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, and 30-day mortality.DiscussionThis trial aimed to assess the effects of low tidal volumes combined with intraoperative PEEP ventilation strategy on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer.Trial registrationID: ChiCTR1800019867. Registered on December 2, 2018.
Highlights
There are increasing studies showing that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery; the appropriate positive end-expiratory pressure (PEEP) has not yet defined
This trial aimed to assess the effects of low tidal volumes combined with intraoperative PEEP ventilation strategy on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer
Objectives of the study This trial aimed to compare the effects of low tidal volumes combined with standard PEEP (6–8 cm H2O) with those of low PEEP (≤2 cm H2O) in patients at risk for complications undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer during general anesthesia in terms of (1) Postoperative pulmonary complication (PPC); (2) modified clinical pulmonary infection score (mCPIS), postoperative extrapulmonary complications, changes in chest x-ray findings, and oxygenation; (3) intraoperative complications, including hypoxemia, hypotension, and massive transfusion; and (4) postoperative surgical complications, intensive care unit (ICU) lengths of stay, hospital lengths of stay, and 30-day mortality
Summary
Prospective, randomized controlled trial of patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer, our aim will be to assess possible single effects of PEEP levels on major PPCs from those of lower tidal volumes and RM and relevant clinical parameters associated with alterations in pulmonary function, such as chest x-ray, abnormalities, mCPIS, arterial oxygenation/peripheral oxygen saturation in air, and changes in dyspnea/cough/secretions. There is an increasing number of highly qualitative randomized controlled trials regarding intraoperative mechanical ventilation and PPCs in both abdominal surgeries [10, 11] and laparoscopic surgeries [32], whereas direct assessment of the effect in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer is still lacking. The included patients will undergo elective robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer with longer anesthesia duration, which is a potential risk factor for PPCs [7]. This trial design includes instructions for fluid management standardization and analgesic treatments during the perioperative period.
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