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NCT Number: NCT04085146

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Difference in lung ultrasound score

    Time frame: 10 min after surgery

    Difference in postoperative lung ultrasound score and baseline lung ultrasound score

Secondary outcomes

  1. Baseline lung ultrasound score

    Time frame: 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

    Time frame: 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

    Time frame: during the postoperative one month

    Length of total hospital stay

  4. Postoperative Lung ultrasound score

    Time frame: 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

    Time frame: during the postoperative one month

    Length of total hospital stay

  6. Surgical wound infection

    Time frame: during the postoperative one month

    The rate of surgical wound infection

  7. Surgical wound dehiscence

    Time frame: during the postoperative one month

    The rate of surgical wound dehiscence

  8. Incidence of acute kidney injury

    Time frame: during the postoperative one month

    Incidence of postoperative acute kidney injury

  9. Incidence of surgical re-intervention

    Time frame: during the postoperative one month

    Incidence of surgical re-open

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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