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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Atelectasis, Postoperative

Intervention / Treatment
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* Procedure: Individualized optimal positive end-expiratory pressure
* Procedure: Conventional positive end-expiratory pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled superiority trial with two arms of intervention.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimal PEEP<br>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<br>* 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).<br>|
| Active Comparator: Conventional PEEP<br>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<br>* A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia