Abstract
BackgroundPatients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.Methods/designA total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.DiscussionThis trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.Trial registrationClinicalTrials.gov, ID: NCT02931409. Registered on 5 October 2016.
Highlights
Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs
Objectives of the study The main objectives of this trial are to compare the effects of a standard Lung-protective mechanical ventilation (LPV) applying 6 cmH2O of positive end-expiratory pressure (PEEP) to a LPV using an individually titrated optimal PEEP on: (1) oxygenation and PPC, (2) the degree of inflammatory response evaluated by early PCT kinetics (0, 2, 6, 12, 24, 48 and 72 h after surgical incision) and (3) to evaluate the relationship between the degree of inflammation and postoperative pulmonary and extrapulmonary complications
Patients randomized into the control group (CG) group will undergo an alveolar recruitment maneuver using the sustained airway pressure by the continuous positive airway pressure (CPAP) method, applying 30 cmH2O PEEP for 30 s followed by low-tidal-volume LPV using a PEEP value of 6 cmH2O and alveolar recruitment maneuvers (ARM) will be repeated every 60 min
Summary
This investigator-initiated, pragmatic, interventional, prospective, randomized controlled trial will assess the possible benefits and disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion as indicated mainly by PPC and the inflammatory response. Radical cystectomy and urinary diversion is considered major surgery with an operating time lasting for several hours. This gives the potential for inappropriate intraoperative ventilatory management causing further harm by exacerbating the surgery-induced inflammatory response, causing more postoperative complications. The potential implications of our results can further improve our knowledge on the effects of optimal intraoperative ventilatory strategies and, in the case of positive results, these may be applicable to patients with bladder cancer undergoing radical cystectomy and urinary diversion, but presumably to all patients undergoing similar types of major abdominal surgery.
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