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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07105293
Enrollment
64
Registered
2025-08-05
Start date
2023-11-01
Completion date
2025-02-01
Last updated
2025-08-05

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

Conditions

Laparoscopy, Positive End Expiratory Pressure (PEEP), Respiratory Mechanics

Keywords

Laparoscopic hysterectomy, PEEP, Postoperative pulmonary complications, Respiratory mechanics, Driving pressure, Tissue oxygenation

Brief 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.

Interventions

OTHERPEEP 5 cmH2o applied group

A 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 group

A 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

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

Patients were randomized into two equal groups; one group received PEEP 5 cmH₂O, while the other received PEEP 10 cmH₂O.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* The study group included patients aged 18-70 years with ASA physical status I-III who were scheduled for elective laparoscopic hysterectomy under general anesthesia between November 1, 2023 and February 15, 2024 and who gave informed consent for participation.

Exclusion criteria

* Previous history of pneumothorax * ASA IV classification * Significant pulmonary impairment (moderate/severe chronic obstructive pulmonary disease, emphysema, pulmonary hypertension, etc.) * Active upper respiratory tract infection or recurrent respiratory infections requiring recent antibiotic treatment * Severe systemic diseases * Heavy smoking (≥20 pack-years) * Emergency surgical cases * Failure to provide written informed consent for any reason * Contraindications to PEEP application

Design outcomes

Primary

MeasureTime frameDescription
Intergroup comparison of near infrared spektroscopy (NIRS) valueDuring the operationComparison of near infrared spektroscopy (NIRS) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg baseline, after intubation, after pneumoperitoneum and after insufflation
Pulmonary OutcomesDuring the operationIt was determined whether pulmonary complications developed and its relationship with the Ariscat score was evaluated. Ariscat score: Low Risk: 0-26 point Middle Risk: 26-44 point Hihg Risk: 45≤ point
Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)During the operationComparison of peak inspiratory pressure (Ppeak) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of plato pressure (Ppeak) value (mmhg)during the operationComparison of plato pressure (Pplato) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of mean airway pressure (Pmean) value (mmhg)during the operationComparison of mean airway pressure (Pmean) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of end tidal carbondioxide (EtCO2) value (mmhg)during the operationsComparison of end tidal carbondioxide (EtCO2) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of driving pressure value (mmhg)during the operationsComparison of driving pressure values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)during the operationsComparison of partial oxygen pressures (pao2) in arterial blood gas between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)during the operationsComparison of partial carbondioxide pressures (PaCO2) in arterial blood gas between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation
Intergroup comparison of lactate valueduring the operationComparison of lactate values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation

Countries

Turkey (Türkiye)

Outcome results

None listed

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