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Individual Optimal Positive End-expiratory Pressure During Robot-assisted Laparoscopic Radical Prostatectomy

Not Applicable
Completed
Conditions
Pulmonary Atelectasis, Postoperative
Interventions
Procedure: Individualized optimal positive end-expiratory pressure
Procedure: Conventional positive end-expiratory pressure
Registration Number
NCT04085146
Lead Sponsor
Seoul National University Hospital
Brief Summary

During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP.

Detailed Description

During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP. We plan to determine the degree of immediate postoperative atelectasis by measuring the lung ultrasound score and compare the lung ultrasound score between groups.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
60
Inclusion Criteria
  • Patients undergoing robot-assisted laparoscopic radical prostatectomy
  • Patients receiving mechanical ventilation by Aisys Care Station anesthesia ventilator
  • Patients who provided written informed consent to participate in this clinical trial
Exclusion Criteria
  • American Society of Anesthesiologists physical status classification class 3 or more
  • Moderate or more obstructive or restrictive pulmonary disease
  • Preoperative adult respiratory distress syndrome or previous history of adult respiratory distress syndrome
  • history of heart failure, unstable angina, increased intracranial pressure
  • history of pneumothorax or presence of bullae

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Optimal PEEPIndividualized optimal positive end-expiratory pressureIndividualized optimal PEEP will be provided during the laparoscopic period of surgery. Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA).
Conventional PEEPConventional positive end-expiratory pressureA same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
Primary Outcome Measures
NameTimeMethod
Difference in lung ultrasound score10 min after surgery

Difference in postoperative lung ultrasound score and baseline lung ultrasound score

Secondary Outcome Measures
NameTimeMethod
Composite of respiratory complicationduring postoperative seven days.

summation of the following events: hypoxemia (pulse oximetry of 95% or less), laryngospasm, bronchospasm, pneumonia, pulmonary infiltration, aspiration pneumonia, pneumonia), pulmonary infiltration, aspiration pneumonia, development of acute respiratory distress syndrome, atelectasis, pleural effusion, pulmonary edema, pneumothorax.

Postoperative Lung ultrasound score10 min after the end of anesthesia

A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination

Length of intensive care unit stayduring the postoperative one month

Length of total hospital stay

Incidence of acute kidney injuryduring the postoperative one month

Incidence of postoperative acute kidney injury

Baseline lung ultrasound score10 min before the start of anesthesia induction

A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination

Length of hospital stayduring the postoperative one month

Length of total hospital stay

Surgical wound infectionduring the postoperative one month

The rate of surgical wound infection

Surgical wound dehiscenceduring the postoperative one month

The rate of surgical wound dehiscence

Incidence of surgical re-interventionduring the postoperative one month

Incidence of surgical re-open

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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