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

Primary Purpose

Pulmonary Atelectasis, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Individualized optimal positive end-expiratory pressure
Conventional positive end-expiratory pressure
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Atelectasis, Postoperative focused on measuring robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optimal PEEP

Conventional PEEP

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Difference in lung ultrasound score
Difference in postoperative lung ultrasound score and baseline lung ultrasound score

Secondary Outcome Measures

Baseline lung ultrasound score
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
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.
Length of hospital stay
Length of total hospital stay
Postoperative Lung ultrasound score
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Length of intensive care unit stay
Length of total hospital stay
Surgical wound infection
The rate of surgical wound infection
Surgical wound dehiscence
The rate of surgical wound dehiscence
Incidence of acute kidney injury
Incidence of postoperative acute kidney injury
Incidence of surgical re-intervention
Incidence of surgical re-open

Full Information

First Posted
September 9, 2019
Last Updated
October 20, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04085146
Brief Title
Individual Optimal Positive End-expiratory Pressure During Robot-assisted Laparoscopic Radical Prostatectomy
Official Title
The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
August 7, 2020 (Actual)
Study Completion Date
August 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Postoperative
Keywords
robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled superiority trial with two arms of intervention.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Anesthesia care-provider cannot be blinded. Surgeon and outcome assessor will be blinded to the group assignment.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal PEEP
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional PEEP
Arm Type
Active Comparator
Arm Description
A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
Intervention Type
Procedure
Intervention Name(s)
Individualized optimal positive end-expiratory pressure
Intervention Description
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
Intervention Name(s)
Conventional positive end-expiratory pressure
Intervention Description
A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
Primary Outcome Measure Information:
Title
Difference in lung ultrasound score
Description
Difference in postoperative lung ultrasound score and baseline lung ultrasound score
Time Frame
10 min after surgery
Secondary Outcome Measure Information:
Title
Baseline lung ultrasound score
Description
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Time Frame
10 min before the start of anesthesia induction
Title
Composite of respiratory complication
Description
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.
Time Frame
during postoperative seven days.
Title
Length of hospital stay
Description
Length of total hospital stay
Time Frame
during the postoperative one month
Title
Postoperative Lung ultrasound score
Description
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Time Frame
10 min after the end of anesthesia
Title
Length of intensive care unit stay
Description
Length of total hospital stay
Time Frame
during the postoperative one month
Title
Surgical wound infection
Description
The rate of surgical wound infection
Time Frame
during the postoperative one month
Title
Surgical wound dehiscence
Description
The rate of surgical wound dehiscence
Time Frame
during the postoperative one month
Title
Incidence of acute kidney injury
Description
Incidence of postoperative acute kidney injury
Time Frame
during the postoperative one month
Title
Incidence of surgical re-intervention
Description
Incidence of surgical re-open
Time Frame
during the postoperative one month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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