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Optimal Ventilation Strategies in Laparoscopic Hysterectomy

B

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Completed

Conditions

Postoperative Pulmonary Complications
Recruitment Maneuver
Individualized PEEP
Total Hysterectomy

Treatments

Procedure: standardized 5 PEEP
Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT07000448
2022-394

Details and patient eligibility

About

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.

Full 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.

Enrollment

113 patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

113 participants in 2 patient groups

individualized PEEP (PEEPi)
Experimental group
Description:
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.
Treatment:
Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
PEEP 5
Active Comparator group
Description:
Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP, and no recruitment maneuver was performed.
Treatment:
Procedure: standardized 5 PEEP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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