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

NCT07105293 | Completed

• 1 other identifier: SBU-AVR-BS-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

PEEP 5 cmH2o applied group

ACTIVE COMPARATOR

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

PEEP 10 cmH2o applied group

ACTIVE COMPARATOR

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

Interventions

PEEP 5 cmH2o applied group OTHER

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

PEEP 5 cmH2o applied group

PEEP 10 cmH2o applied group OTHER

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

PEEP 10 cmH2o applied group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

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

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 5, 2025
• Study Start: November 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)