Optimal Ventilation Strategies in Laparoscopic Hysterectomy

NCT ID: NCT07000448

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-09
• Study Completion Date: 2024-06-26

Brief Summary

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.

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.

Conditions

Recruitment Maneuver; Individualized PEEP; Total Hysterectomy; Postoperative Pulmonary Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Intervention Type: PROCEDURE

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

PEEP 5

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

Group Type: ACTIVE_COMPARATOR

standardized 5 PEEP

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

standardized 5 PEEP

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Beyhan Guner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beyhan Guner, MD

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-394

Identifier Type: -

Identifier Source: org_study_id