Clinical trial NCT04085146: Individual Optimal Positive End-expiratory Pressure During Robot-assisted Laparoscopic Radical Prostatectomy
Official title: The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis, Postoperative
Keywords: robot-assisted surgery
prostatectomy
laparoscopy
positive end-expiratory pressure
individualized
atelectasis
general anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled superiority trial with two arms of intervention.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in lung ultrasound score
timeFrame: 10 min after surgery
Secondary outcomes:
measure: Baseline lung ultrasound score
timeFrame: 10 min before the start of anesthesia induction
measure: Composite of respiratory complication
timeFrame: during postoperative seven days.
measure: Length of hospital stay
timeFrame: during the postoperative one month
measure: Postoperative Lung ultrasound score
timeFrame: 10 min after the end of anesthesia
measure: Length of intensive care unit stay
timeFrame: during the postoperative one month
measure: Surgical wound infection
timeFrame: during the postoperative one month
measure: Surgical wound dehiscence
timeFrame: during the postoperative one month
measure: Incidence of acute kidney injury
timeFrame: during the postoperative one month
measure: Incidence of surgical re-intervention
timeFrame: during the postoperative one month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: