Skip to main content
OpenTrials
Completed

NCT Number: NCT07105293

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laparoscopy Positive End Expiratory Pressure (PEEP) Respiratory Mechanics

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. Intergroup comparison of near infrared spektroscopy (NIRS) value

    Time frame: During the operation

    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

  2. Pulmonary Outcomes

    Time frame: During the operation

    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

  3. Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)

    Time frame: During the operation

    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

  4. Intergroup comparison of plato pressure (Ppeak) value (mmhg)

    Time frame: during the operation

    Comparison of plato pressure (Pplato) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation

  5. Intergroup comparison of mean airway pressure (Pmean) value (mmhg)

    Time frame: during the operation

    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

  6. Intergroup comparison of end tidal carbondioxide (EtCO2) value (mmhg)

    Time frame: during the operations

    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

  7. Intergroup comparison of driving pressure value (mmhg)

    Time frame: during the operations

    Comparison of driving pressure values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation

  8. Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)

    Time frame: during the operations

    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

  9. Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)

    Time frame: during the operations

    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

  10. Intergroup comparison of lactate value

    Time frame: during the operation

    Comparison of lactate values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.