Inflammatory Response Clinical Trial
Official title:
Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response. A Double-center, Prospective, Randomized Controlled Trial
The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. A total number of 40 patients undergoing open radical cystectomy and urinary diversion will be enrolled and randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will be performed in control group and an optimal PEEP value determined during a static pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery until the third postoperative day as well as postoperative pulmonary complications. Clinical condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.
Patients undergoing general anesthesia and mechanical ventilation during major abdominal
surgery commonly develop pulmonary atelectasis or even hyperdistension of the lungs can occur
leading to adverse consequences either intraoperatively or postoperatively. Lung protective
ventilation (LPV, PEEP = 6 cmH2O, TV = 6 mL/Kg IBW and regular recruitments) during the
intraoperative period can reduce the risk of ventilator induced lung injury (VILI) and
prevent the formation of pulmonary atelectasis.
In our investigator-initiated, double-center, single-blinded, prospective, randomized,
controlled clinical trial a 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 two groups. Standard lung protective mechanical
ventilation with the use of 6 cmH2O of PEEP and low tidal volumes (6mL/Kg IBW), a fraction of
inspired oxygen (FiO2) of 0.5 and a respiratory rate to maintain an end tidal carbon dioxide
(ETCO2) between 35-40 mmHg will be performed in control group, and a strategy of lung
protective mechanical ventilation applying an optimal, individual PEEP determined by static
pulmonary compliance (Cstat) directed PEEP titration procedure will be performed in study
group.
During preoperative assessment, respiratory failure risk index (RFRI) will be recorded and
informed consent will be obtained. Regarding to the protocol, a central vein catheter will be
placed on the day before surgery, serum procalcitonin (PCT) level will be measured and a
chest X-ray examination will be performed.
Before induction of anesthesia, an epidural catheter and an arterial canula for invasive
blood pressure monitoring will be inserted. Immediately after induction of anesthesia and
orotracheal intubation, all patients will be submitted to an alveolar recruitment maneuver
(ARM) using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30
seconds. After ARM PEEP will be set to 6 cmH2O in the control group ("standard PEEP") and LPV
will be performed. In the study group ("optimal PEEP") PEEP will be set to 14 cmH2O and a
Cstat directed decremental PEEP titration procedure will be performed (every 4 minutes PEEP
will be decreased by 2 cmH2O, until a final PEEP of 6 cmH2O) to determine the best individual
PEEP. During surgery ARM will be repeated and arterial and central vein blood gas samples
(ABGs, CVBGs) will be evaluated every 60 minutes. PCT levels will be measured 2, 6, 12, 24,
48 and 72 hours after surgical incision.
After extubation, patients will be addmitted to the Department of Anesthesiology and
Intensive Care. ABGs and CVBGs will be collected and evaluated, PaO2/FiO2 and dCO2 will be
calculated every 6 hours until 72 hours after surgery. On the first postoperative day chest
X-ray will be performed and repeated on the following days if developing of pulmonary
complications were suspected. Continuous epidural analgesia will be introduced, and evaluated
effective if numeric pain rating scale point would be lower than 3 points.
During postoperative care continuous intraabdominal pressure (IAP) monitoring via a direct
intraperitoneal catheter placed before closure of the abdominal wall will be performed to
eliminate bias caused by the elevation of intraabdominal pressure.
Patients' clinical progress and secondary endpoints will be monitored by daily SOFA Scores,
laboratory and physical examinations.
During follow-up period in-hospital stay, 28-days and in-hospital mortality will also be
evaluated.
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