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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Atelectasis, Postoperative
• Intervention / Treatment: Procedure: Individualized optimal positive end-expiratory pressure; Procedure: Conventional positive end-expiratory pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Optimal PEEP; Individualized 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).	Procedure: Individualized 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).
ACTIVE_COMPARATOR: Conventional PEEP; A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.	Procedure: Conventional positive end-expiratory pressure; A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in lung ultrasound score	Difference in postoperative lung ultrasound score and baseline lung ultrasound score	10 min after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline lung ultrasound score	A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination	10 min before the start of anesthesia induction
Composite of respiratory complication	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.	during postoperative seven days.
Length of hospital stay	Length of total hospital stay	during the postoperative one month
Postoperative Lung ultrasound score	A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination	10 min after the end of anesthesia
Length of intensive care unit stay	Length of total hospital stay	during the postoperative one month
Surgical wound infection	The rate of surgical wound infection	during the postoperative one month
Surgical wound dehiscence	The rate of surgical wound dehiscence	during the postoperative one month
Incidence of acute kidney injury	Incidence of postoperative acute kidney injury	during the postoperative one month
Incidence of surgical re-intervention	Incidence of surgical re-open	during the postoperative one month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2019
• Primary Completion (ACTUAL): August 7, 2020
• Study Completion (ACTUAL): August 7, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: atelectasis; general anesthesia; laparoscopy; robot-assisted surgery; positive end-expiratory pressure; prostatectomy; individualized
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 1908-022-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No