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

Pulmonary Atelectasis, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085146
• Other study ID #: 1908-022-105
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: August 7, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Atelectasis
• Pulmonary Atelectasis, Postoperative

Intervention

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).
• Conventional positive end-expiratory pressure
A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in lung ultrasound score	Difference in postoperative lung ultrasound score and baseline lung ultrasound score	10 min after surgery
Secondary	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
Secondary	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.
Secondary	Length of hospital stay	Length of total hospital stay	during the postoperative one month
Secondary	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
Secondary	Length of intensive care unit stay	Length of total hospital stay	during the postoperative one month
Secondary	Surgical wound infection	The rate of surgical wound infection	during the postoperative one month
Secondary	Surgical wound dehiscence	The rate of surgical wound dehiscence	during the postoperative one month
Secondary	Incidence of acute kidney injury	Incidence of postoperative acute kidney injury	during the postoperative one month
Secondary	Incidence of surgical re-intervention	Incidence of surgical re-open	during the postoperative one month