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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04085146
Collaborator
(none)
60
1
2
8.6
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Individualized optimal positive end-expiratory pressure
  • Procedure: Conventional positive end-expiratory pressure
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled superiority trial with two arms of intervention.Randomized controlled superiority trial with two arms of intervention.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Anesthesia care-provider cannot be blinded. Surgeon and outcome assessor will be blinded to the group assignment.
Primary Purpose:
Prevention
Official Title:
The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
Actual Study Start Date :
Nov 19, 2019
Actual Primary Completion Date :
Aug 7, 2020
Actual Study Completion Date :
Aug 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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).

Active Comparator: Conventional PEEP

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

Outcome Measures

Primary Outcome Measures

  1. Difference in lung ultrasound score [10 min after surgery]

    Difference in postoperative lung ultrasound score and baseline lung ultrasound score

Secondary Outcome Measures

  1. Baseline lung ultrasound score [10 min before the start of anesthesia induction]

    A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination

  2. Composite of respiratory complication [during postoperative seven days.]

    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.

  3. Length of hospital stay [during the postoperative one month]

    Length of total hospital stay

  4. Postoperative Lung ultrasound score [10 min after the end of anesthesia]

    A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination

  5. Length of intensive care unit stay [during the postoperative one month]

    Length of total hospital stay

  6. Surgical wound infection [during the postoperative one month]

    The rate of surgical wound infection

  7. Surgical wound dehiscence [during the postoperative one month]

    The rate of surgical wound dehiscence

  8. Incidence of acute kidney injury [during the postoperative one month]

    Incidence of postoperative acute kidney injury

  9. Incidence of surgical re-intervention [during the postoperative one month]

    Incidence of surgical re-open

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won Ho Kim, MD, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04085146
Other Study ID Numbers:
  • 1908-022-105
First Posted:
Sep 11, 2019
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Won Ho Kim, MD, Associate Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021