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OpenTrials
Completed

NCT Number: NCT07000448

Optimal Ventilation Strategies in Laparoscopic Hysterectomy

The aim of this study was to investigate whether individualized PEEP application improves respiratory function and reduces the incidence of postoperative pulmonary complications (PPCs) in patients undergoing laparoscopic total hysterectomy. Investigators hypothesized that individualized PEEP would improve pulmonary oxygenation and reduce the incidence of postoperative pulmonary complications.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

About this study

The study included 113 patients who met the criteria and underwent elective laparoscopic total hysterectomy.

In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. During this maneuver, the ventilator was switched to pressure-controlled mode, the I:E ratio was increased to 1:1, FiO₂ was increased to 80%, and the respiratory rate was set to 15/min. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every 5 respiratory cycles, and an airway opening pressure of 40 cmH₂O was obtained.

For optimal individual PEEP titration, the dynamic compliance values observed on the ventilator monitor were recorded when the PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles, and the PEEP level at which the highest compliance value was obtained was determined. The value 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. The recruitment maneuver was repeated at specified time points during the surgical procedure and upon disconnection of the ventilator circuit.

Data collection was performed at several time points; before induction (T1), only hemodynamic data were recorded. Before pneumoperitoneum, 5 minutes after induction (T2) with the patient in the supine position, 20 minutes after the onset of pneumoperitoneum (T3) in the Trendelenburg position, and 60 minutes after the onset of pneumoperitoneum (T4) mechanical ventilation and hemodynamic parameters were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Scheduled for elective laparoscopic total hysterectomy
  • ASA physical status I-III
  • BMI ≤30 kg/m²
  • Anticipated surgical duration >2 hours

Exclusion criteria

  • Pre-existing neuromuscular disorders
  • NYHA class III/IV heart failure
  • OSAS
  • Previous lung surgery
  • Severe pulmonary disease (FEV1 <50% predicted)

Treatment and study plan

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Procedure

For optimal individual PEEP titration, dynamic compliance values observed on the ventilator monitor were recorded when PEEP reached 20 cmH₂O.

standardized 5 PEEP

Procedure

Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP and no recruitment maneuver was performed.

Primary outcomes

  1. Postoperative pulmonary complications (PPC)

    Time frame: within 7 days after surgery

    PPC included clinical conditions such as atelectasis, hypoxemia (PaO₂ < 8.0 kPa or SpO₂ < 90% on room air), pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, bronchospasm, pneumothorax, reintubation or need for non-invasive ventilation support.

Secondary outcomes

  1. Intraoperative respiratory mechanics parameter

    Time frame: within intraoperative period

    Driving pressure

  2. Respiratory mechanics parameter

    Time frame: intraoperatively

    Dynamic compliance

  3. Mechanic ventilation parameter

    Time frame: during intraoperative period

    Pplatteau

  4. Intensive care

    Time frame: within 7 days after surgery

    Intensive care unit (ICU) admission

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Effects of Personalized PEEP Titration on Postoperative Pulmonary Outcomes in Laparoscopic Hysterectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2025
Registry last updated
Sep 22, 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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