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

NCT04085146 | Completed

• 1 other identifier: 1908-022-105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Atelectasis, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in lung ultrasound score

  Difference in postoperative lung ultrasound score and baseline lung ultrasound score

  10 min after surgery

Secondary Outcomes (9)

• Baseline lung ultrasound score

  10 min before the start of anesthesia induction

• Composite of respiratory complication

  during postoperative seven days.

• Length of hospital stay

  during the postoperative one month

• Postoperative Lung ultrasound score

  10 min after the end of anesthesia

• Length of intensive care unit stay

  during the postoperative one month

Study Arms (2)

Optimal PEEP

EXPERIMENTAL

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

Conventional PEEP

ACTIVE COMPARATOR

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

Interventions

Individualized optimal positive end-expiratory pressure 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).

Optimal PEEP

Conventional positive end-expiratory pressure PROCEDURE

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

Conventional PEEP

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Anesthesia care-provider cannot be blinded. Surgeon and outcome assessor will be blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled superiority trial with two arms of intervention.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: November 19, 2019
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)