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

NCT ID: NCT04085146

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2020-08-07

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.

Conditions

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Pulmonary Atelectasis, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled superiority trial with two arms of intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

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

Study Groups

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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).

Group Type EXPERIMENTAL

Individualized optimal positive end-expiratory pressure

Intervention Type PROCEDURE

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 PEEP

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

Group Type ACTIVE_COMPARATOR

Conventional positive end-expiratory pressure

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1908-022-105

Identifier Type: -

Identifier Source: org_study_id