Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2116-z) contains supplementary material, which is available to authorized users.

Individualized lung protective ventilation vs. conventional ventilation during general anesthesia in laparoscopic total hysterectomy

“…In the PV group, the ventilation protocol settings were the same as those in the CV group immediately after induction of anesthesia and orotracheal intubation. However, once a steady state had been reached, all patients were submitted to an ARM using sustained airway pressure via the CPAP method, applying TV of 7 ml/kg IBW and 30 cm H 2 O PEEP for 30 sec based on a study by Ruszkai et al (28), followed by a decremental PEEP titration (DPT) procedure directed by Cstat. The depth of anesthesia was regulated to ensure the patients were haemodynamically stable and a PaO 2 /FiO 2 of ≥300 mmHg was also guaranteed to assure that the pulmonary oxygenation function was normal.…”

“…The method of DPT was as follows (28): During the PEEP titration procedure, PEEP was decreased from 14 cm H 2 O by 2 cm H 2 O every 4 min, until a final PEEP of 6 cm H 2 O was reached. On each level of PEEP, Cstat was measured by the ventilator.…”

Effects of intraoperative PEEP on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer: study protocol for a randomized controlled trial

“…IBW is calculated with formulas as follows [13]: 45.5 + 0.91 x (centimeters of height -152.4) for females and 50 + 0.91 x (centimeters of height -152.4) for males. Recruitment maneuvers (RMs) [21] will be performed immediately after tracheal intubation and every time ventilator is interrupted until the end of surgery in each group. The compliance of the respiratory system will be calculated with the formulas of VT/ (plateau pressure of the respiratory system -PEEP).…”

“…Primary outcome measure The primary endpoint was PPCs including new atelectasis or infiltrates on a chest X-ray or CT scanning, respiratory failure defined as the need for noninvasive or invasive ventilation or partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) < 300 within 7 days after surgery [21].…”

Effects of Intraoperative PEEP on Postoperative Pulmonary Complications in Patients Undergoing Robot-assisted Laparoscopic Radical Resection for Bladder Cancer or Prostate Cancer: Study Protocol for a Randomized Controlled Trial

“…IBW is calculated with formulas as follows[13]: 45.5 + 0.91 x (centimeters of height -152.4) for females and 50 + 0.91 x (centimeters of height -152.4) for males. Recruitment maneuvers (RMs)[21] will be performed immediately after tracheal intubation and every time ventilator is interrupted until the end of surgery in each group. The compliance of the respiratory system will be calculated with the formulas of VT/ (plateau pressure of the respiratory system -PEEP).…”