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Optimal Ventilation Strategies in Laparoscopic Hysterectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07000448
Enrollment
113
Registered
2025-06-03
Start date
2022-12-09
Completion date
2024-06-26
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

PROCEDUREstandardized 5 PEEP

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

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pulmonary complications (PPC)within 7 days after surgeryPPC 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

MeasureTime frameDescription
Intraoperative respiratory mechanics parameterwithin intraoperative periodDriving pressure
Respiratory mechanics parameterintraoperativelyDynamic compliance
Mechanic ventilation parameterduring intraoperative periodPplatteau
Intensive carewithin 7 days after surgeryIntensive care unit (ICU) admission

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026