NCT02931409.

Trial name or title	Intra‐operative PEEP optimisation: effects on postoperative pulmonary complications and inflammatory response
Methods	Randomised trial, parallel assignment, single‐blind in Hungary
Participants	Inclusion criteria: patients with bladder cancer undergoing radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) Exclusion criteria: age < 18 years American society of Anesthesiology risk class IV history of severe COPD (GOLD grade III or IV) history of severe or uncontrolled bronchial asthma history of severe restrictive pulmonary disease pulmonary metastases history of any thoracic surgery need for thoracic drainage before surgery renal replacement therapy prior to surgery congestive heart failure (NYHA grade III or IV) extreme obesity (BMI > 35 kg/m2) lack of patient's consent
Interventions	Algorithm used in this study: Experimental: Optimal PEEP patients submitted to general anaesthesia and open radical cystectomy and urinary diversion (20 participants) will be submitted an alveolar recruitment maneuver using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a decremental PEEP titration procedure directed by static pulmonary compliance (Cstat). During PEEP titration procedure, PEEP will be decreased from 14 cmH2O by 2 cmH2O every 4 minutes, until a final PEEP of 6 cmH2O. Optimal PEEP is considered to be a PEEP value resulting the highest possible Cstat measured by ventilator. After PEEP titration procedure, a lung protective mechanical ventilation will be performed using optimal PEEP and low tidal volumes. Active comparator: Standard PEEP. Patients submitted to general anaesthesia and open radical cystectomy and urinary diversion (20 participants) will be submitted an alveolar recruitment manoeuvre using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a standard lung protective mechanical ventilation using a PEEP value of 6 cmH2O and low tidal volumes (6 mL/kg)
Outcomes	Postoperative Pulmonary Complications: new infiltrates or atelectasis on chest X‐ray, abnormal breathing sounds on auscultation, excessive bronchial secretions, unexplained fever, respiratory failure or need for non‐invasive or invasive ventilatory support. Procalcitonin Kinetics: serum procalcitonin levels during and after surgery
Starting date	October 2016
Contact information	Zoltán Ruszkai, MD; ruszkai.zoltan@peterfykh.hu
Notes	Collaborator: Péterfy Sándor Hospital, Szeged University Registration: NCT02931409

AB: antibiotic
 ACCP: American College of Chest Physicians
 APACHE II: Acute Physiology and Chronic Health Evaluation II
 BMI: body mass index
 BNP: B‐type natriuretic peptide
 COPD: chronic obstructive pulmonary disease
 CPAP: continuous positive airway pressure
 CRP: C‐reactive protein
 CT: computed tomography
 d: day
 ED: emergency department
 ESBL: extended‐spectrum beta‐lactamase
 h: hour
 GOLD: Global Initiative for Chronic Obstructive Lung Disease
 ICU: intensive care unit
 LRTI: lower respiratory tract infection
 NT‐proBNP: N‐terminal pro‐B‐type natriuretic peptide
 NYHA: New York Heart Association
 Pa: arterial
 PaO₂/FiO₂: relationship between arterial oxygen tension (PaO₂) and inspiratory oxygen fraction (FiO₂)
 PCT: procalcitonin
 PEEP: positive end‐expiratory pressure
 PORT: Pneumonia Patient Outcomes Research Team
 RCT: randomised controlled trial
 SIRS: systemic inflammatory response syndrome
 SOFA: Sequential Organ Failure Assessment score