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Trials / Completed

CompletedNCT07105293

Effects of Different Peep Applications on Tissue Oxygenation, Respiratory Mechanics and Postoperative Pulmonary Complications in Laparoscopic Hysterectomy Operations

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This study aims to compare the effects of two different PEEP levels (5 cmH₂O and 10 cmH₂O) during laparoscopic hysterectomy on perioperative tissue and cerebral oxygenation, respiratory mechanics, and postoperative pulmonary complications.

Detailed description

Laparoscopic surgery is frequently performed today due to its rapid recovery, short hospital stay, minimal incisions, and minimal postoperative pain. Despite these advantages of laparoscopic hysterectomy, the patient's Trendelenburg position and pneumoperitoneum can cause abdominal organs to shift to the diaphragm, decrease lung compliance, atelectasis, and ultimately compromise respiratory function and mechanics. Tissue hypoxia occurs, affecting cerebral perfusion. Consequently, these patients are prone to perioperative hypoxemia and postoperative pulmonary complications. PEEP can improve arterial oxygenation and reduce atelectasis. The aim of this study was to compare the effectiveness of PEEP in terms of perioperative tissue oxygenation, cerebral perfusion, respiratory mechanics, and postoperative pulmonary complications. The study was planned to include 64 patients aged 18-75 years, with ASA status I-III, who provided informed consent and were undergoing elective laparoscopic hysterectomy. The patients were randomized into two groups: one with PEEP 5 cmH₂O and the other with PEEP 10 cmH₂O. The aim was to compare the two groups' hemodynamic variables, NIRS values, peak inspiratory pressure (Ppeak), plateau pressure (Pplato), mean airway pressure (Pmean), end-tidal CO₂ (EtCO₂), driving pressure, serum lactate, partial arterial oxygen (PaO2), and carbon dioxide (PaCO2) levels, recorded after intubation, 30 minutes after pneumoperitoneum, and 15 minutes after desufflation. The ARISCAT score was used to assess the risk of any postoperative pulmonary complications.

Conditions

Interventions

TypeNameDescription
OTHERPEEP 5 cmH2o applied groupA standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min, PEEP:5 cmH2o
OTHERPEEP 10 cmH2o applied groupA standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min, PEEP:10 cmH2o

Timeline

Start date
2023-11-01
Primary completion
2024-02-15
Completion
2025-02-01
First posted
2025-08-05
Last updated
2025-08-05

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07105293. Inclusion in this directory is not an endorsement.