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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Respiratory Mechanics; Positive End Expiratory Pressure (PEEP)
• Intervention / Treatment: Other: PEEP 5 cmH2o applied group; Other: PEEP 10 cmH2o applied group

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Kartal Dr. Lütfi Kirdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEEP 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. Patients were randomized into two equal groups; one group received PEEP 5 cmH₂O	Other: PEEP 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
Active Comparator: PEEP 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. Patients were randomized into two equal groups; one group received PEEP 10 cmH₂O	Other: PEEP 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intergroup comparison of near infrared spektroscopy (NIRS) value	Comparison 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	During the operation
Pulmonary Outcomes	It 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	During the operation
Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)	Comparison of peak inspiratory pressure (Ppeak) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	During the operation
Intergroup comparison of plato pressure (Ppeak) value (mmhg)	Comparison of plato pressure (Pplato) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	during the operation
Intergroup comparison of mean airway pressure (Pmean) value (mmhg)	Comparison of mean airway pressure (Pmean) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	during the operation
Intergroup comparison of end tidal carbondioxide (EtCO2) value (mmhg)	Comparison of end tidal carbondioxide (EtCO2) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	during the operations
Intergroup comparison of driving pressure value (mmhg)	Comparison of driving pressure values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	during the operations
Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)	Comparison 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	during the operations
Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)	Comparison 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	during the operations
Intergroup comparison of lactate value	Comparison of lactate values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation	during the operation

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: June 25, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Respiratory mechanics; PEEP; Tissue oxygenation; Laparoscopic hysterectomy; Driving pressure
• Other Study ID Numbers: SBU-AVR-BS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No