Effects of Different Peep Applications on Tissue Oxygenation, Respiratory Mechanics and Postoperative Pulmonary Complications in Laparoscopic Hysterectomy Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Intergroup comparison of near infrared spektroscopy (NIRS) value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: PEEP 5 cmH2o applied group (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. Patients were randomized into two equal groups; one group received PEEP 10 cmH₂O
干预措施: PEEP 10 cmH2o applied group (Other)
结局指标
主要结局
Intergroup comparison of near infrared spektroscopy (NIRS) value
时间窗: 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
Pulmonary Outcomes
时间窗: 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
Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)
时间窗: 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
Intergroup comparison of driving pressure value (mmhg)
时间窗: 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
Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)
时间窗: 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
Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)
时间窗: 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
Intergroup comparison of lactate value
时间窗: 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
Intergroup comparison of near infrared spektroscopy (NIRS) value
时间窗: 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
Pulmonary Outcomes
时间窗: 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
Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)
时间窗: 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
Intergroup comparison of plato pressure (Ppeak) value (mmhg)
时间窗: 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
Intergroup comparison of mean airway pressure (Pmean) value (mmhg)
时间窗: 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
Intergroup comparison of end tidal carbondioxide (EtCO2) value (mmhg)
时间窗: 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
Intergroup comparison of driving pressure value (mmhg)
时间窗: 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
Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)
时间窗: 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
Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)
时间窗: 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
Intergroup comparison of lactate value
时间窗: 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
次要结局
未报告次要终点
研究者
Büşra Şabano
Research Assistant
Dr. Lutfi Kirdar Kartal Training and Research Hospital