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

The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04085146
Enrollment
60
Registered
2019-09-11
Start date
2019-11-19
Completion date
2020-08-07
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Atelectasis, Postoperative

Keywords

robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia

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.

Interventions

PROCEDUREIndividualized optimal positive end-expiratory pressure

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).

PROCEDUREConventional positive end-expiratory pressure

A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Anesthesia care-provider cannot be blinded. Surgeon and outcome assessor will be blinded to the group assignment.

Intervention model description

Randomized controlled superiority trial with two arms of intervention.

Eligibility

Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in lung ultrasound score10 min after surgeryDifference in postoperative lung ultrasound score and baseline lung ultrasound score

Secondary

MeasureTime frameDescription
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.
Length of hospital stayduring the postoperative one monthLength of total hospital stay
Postoperative Lung ultrasound score10 min after the end of anesthesiaA 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 monthLength of total hospital stay
Baseline lung ultrasound score10 min before the start of anesthesia inductionA scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Surgical wound dehiscenceduring the postoperative one monthThe rate of surgical wound dehiscence
Incidence of acute kidney injuryduring the postoperative one monthIncidence of postoperative acute kidney injury
Incidence of surgical re-interventionduring the postoperative one monthIncidence of surgical re-open
Surgical wound infectionduring the postoperative one monthThe rate of surgical wound infection

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026