Optimal Ventilation Strategies in Laparoscopic Hysterectomy

NCT07000448 | Completed

• 1 other identifier: 2022-394
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intraoperative respiratory mechanics parameter

  within intraoperative period

• Respiratory mechanics parameter

  intraoperatively

• Mechanic ventilation parameter

  during intraoperative period

• Intensive care

  within 7 days after surgery

Study Arms (2)

individualized PEEP (PEEPi)

EXPERIMENTAL

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

PEEP 5

ACTIVE COMPARATOR

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

Procedure: standardized 5 PEEP

Interventions

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.

individualized PEEP (PEEPi)

standardized 5 PEEP PROCEDURE

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

PEEP 5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Study Officials

• Beyhan Guner, MD

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 3, 2025
• Study Start: December 9, 2022
• Primary Completion: April 25, 2024
• Study Completion: June 26, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)