Clinical Trials Directory

Trials / Completed

CompletedNCT07000448

Optimal Ventilation Strategies in Laparoscopic Hysterectomy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
113 (actual)
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
Sex
Female
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREDynamic compliance guided individualized positive end-expiratory pressure titration strategyFor optimal individual PEEP titration, dynamic compliance values observed on the ventilator monitor were recorded when PEEP reached 20 cmH₂O.
PROCEDUREstandardized 5 PEEPPatients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP and no recruitment maneuver was performed.

Timeline

Start date
2022-12-09
Primary completion
2024-04-25
Completion
2024-06-26
First posted
2025-06-03
Last updated
2025-09-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07000448. Inclusion in this directory is not an endorsement.