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Completed

NCT Number: NCT06909630

Individualized PEEP and Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery

In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.

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Key information

Conditions

Lung Collapse Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

19 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SNUBH

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • elective RALP surgery under genenal anesthesia
  • ASA 1-2
  • 19 years of age or older
  • Consented to participate in the study

Exclusion criteria

  • Do not consent to participate in the study
  • ≥ BMI 40 kg/m2
  • Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests
  • Preoperative serious cardiovascular disease
  • Required postoperative ventilator care at ICU care

Treatment and study plan

Driving pressure group

Other

individual PEEP

Primary outcomes

  1. Post operative pulmonary complication(PPC)

    Time frame: up to PostOperative Day(POD) #3

    Post operative lung complication

Secondary outcomes

  1. Individual ventilatory setting

    Time frame: during opertaion

    PEEP in cmH2O at mechanical ventilation setting static lung compliance in liters/cmH2O at measured mechanical ventilation and calculated driving pressure in cmH20 Driving pressure (DP or ΔP) is defined as the distending pressure above the applied positive end-expiratory pressure (PEEP) required to generate tidal volume (VT)

    • C stat= tidal volume/ Driving pressure
    • Driving pressure= tidal volume/C stat

  2. blood pressure(hypotension)

    Time frame: during opertaion

    Types and dosages of vasopressor agents used when the mean blood pressure is ≤ 60 mmHg.

    ** vasopressor agents: Ephedrine, phenylepherine, Norepinepherine

    • Ephedrine single intravenous injection: 5mg
    • phenylepherine single intravenous injection: 20mcg continueous infusion: mcg/kg/min at 100mcg/cc
    • Norepinepherine continueous infusion: mcg/kg/min at 10mcg/cc

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

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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