Optimal Ventilation Strategies in Laparoscopic Hysterectomy

Effects of Personalized PEEP Titration on Postoperative Pulmonary Outcomes 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pulmonary Complications; Recruitment Maneuver; Individualized PEEP; Total Hysterectomy
• Intervention / Treatment: Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy; Procedure: standardized 5 PEEP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey (Türkiye), 34147
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: individualized PEEP (PEEPi); In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every five respiratory cycles, and an airway opening pressure of 40 cmH₂O was achieved. Dynamic compliance values observed on the ventilator monitor were recorded for optimal individual PEEP titration when PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles to determine the PEEP level at which the highest compliance value was achieved. 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery.	Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy; For optimal individual PEEP titration, dynamic compliance values observed on the ventilator monitor were recorded when PEEP reached 20 cmH₂O.
Active Comparator: PEEP 5; Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP, and no recruitment maneuver was performed.	Procedure: standardized 5 PEEP; Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP and no recruitment maneuver was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pulmonary complications (PPC)	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.	within 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care	Intensive care unit (ICU) admission	within 7 days after surgery
Intraoperative respiratory mechanics parameter	Driving pressure	within intraoperative period
Respiratory mechanics parameter	Dynamic compliance	intraoperatively
Mechanic ventilation parameter	Pplatteau	during intraoperative period

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Beyhan Guner, MD, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: May 30, 2025
• First Posted (Actual): June 3, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No