Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Intraoperative and Postoperative Gas Exchange (PaO2/FiO2 Ratio)
研究概览
简要总结
The goal of this clinical trial is to learn if lung-protective ventilation can improve perioperative oxygenation and reduce postoperative pulmonary complications in patients undergoing elective laparoscopic gastrectomy. The main questions it aims to answer are:
- Does lung-protective ventilation improve intraoperative and postoperative gas exchange compared to conventional ventilation?
- What are the effects of this ventilation strategy on pulmonary mechanics, hemodynamic parameters, and the incidence of postoperative pulmonary complications?
Researchers will compare lung-protective ventilation to conventional ventilation to see if the protective strategy safely mitigates atelectasis and improves oxygenation during surgery. Participants will:
- Receive either conventional ventilation or lung-protective ventilation (using lower tidal volumes with appropriate PEEP and recruitment maneuvers) while under general anesthesia for their surgery.
- Have their gas exchange, pulmonary mechanics, and hemodynamic parameters continuously monitored during and after the operation.
- Be assessed for any postoperative pulmonary complications following the surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years scheduled for elective laparoscopic gastrectomy with ananticipated operative time > 3 hours.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Body mass index (BMI) < 30 kg/m².
排除标准
- •Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
- •Gestational hypertension or chronic hypertension
- •Body mass index (BMI) ≥ 35 kg/m²
- •Known allergy to dexamethasone
- •Current long-term corticosteroid therapy
- •Diagnosis of postpartum hemorrhage
研究组 & 干预措施
Conventional Ventilation
干预措施: Conventional Ventilation (Procedure)
Lung-Protective Ventilation
干预措施: Lung-Protective Ventilation (Procedure)
结局指标
主要结局
Intraoperative and Postoperative Gas Exchange (PaO2/FiO2 Ratio)
时间窗: Assessed at 4 specific time points: T1: Baseline (before induction of anesthesia). T2: 1 hour after the start of CO2 pneumoperitoneum. T3: 30 minutes after tracheal extubation. T4: Postoperative day 1 (approximately 24 hours after surgery).
The ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2). This index is used to evaluate the efficiency of pulmonary gas exchange and oxygenation status. PaO2 values are obtained from arterial blood gas (ABG) analysis. A higher ratio indicates better oxygenation.
次要结局
- Peak Inspiratory Pressure (Ppeak)(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Driving Pressure (Pdriving)(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Plateau Pressure (Pplat)(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Dynamic Lung Compliance (Cdyn)(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Static Lung Compliance (Cstat)(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Intraoperative Mean Arterial Pressure(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Intraoperative Heart Rate(Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).)
- Incidence of Intraoperative Hypotension and Vasopressor Use(During the anesthesia and surgical procedure.)
- Incidence of Postoperative Pulmonary Complications(Atelectasis and pneumothorax assessed on postoperative day 1; pneumonia and ARDS assessed within 7 days after surgery.)
- Incidence of Intensive Care Unit (ICU) Admission(Up to 7 days postoperatively)
- Length of Hospital Stay(From the date of surgery until hospital discharge, assessed up to 30 days.)