Effect of Individualized PEEP Titration on Postoperative Pulmonary Complications in Elderly Patients Undergoing Major Laparoscopic Surgery- A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- postoperative pulmonary complications
研究概览
简要总结
This study aims to investigate the effectiveness and safety of implementing a personalized positive end-expiratory pressure (PEEP) management strategy guided by esophageal pressure (Pes), as well as its potential to reduce the occurrence of postoperative pulmonary complications (PPCs) in elderly patients undergoing laparoscopic surgery.
详细描述
This trial is a single-blind, randomized, controlled, multicenter study. Elderly patients undergoing laparoscopic surgery under general anesthesia will be recruited according the inclusion and exclusion criteria. Participants in this study will be randomly assigned into two groups. The total sample size will be 232, with 116 participants in the experimental group and 116 participants in the control group. A stratified block randomization method will be employed, using the ARISCAT score for PPCs risk assessment and individual study centers as stratification factors. Anesthesia routine will be applied during pre-anesthetic preparation, anesthetic induction, maintenance and emergence except intraoperative respiratory management. In the control group, fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers. While in the experimental group (Pes-Guided Group), continuous monitoring of end-expiratory esophageal pressure (Pes) is conducted. PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration (PL = PEEP - Pes) after lung recruitment. PEEP titration following lung recruitment should be performed after endotracheal intubation or any procedure that may cause lung collapse, such as pneumoperitoneum, deflation or inflation of the endotracheal tube cuff, changes in position, or endotracheal suctioning. PEEP Titration is also required every hour after the establishment of pneumoperitoneum. Patients will be followed up within 7 days after surgery to assess basic vital signs, potential postoperative pulmonary complications (PPCs). Additionally, postoperative non-respiratory complications will be evaluated. Laboratory tests, the 15-item Quality of Recovery-15 (QoR-15) questionnaire, complications within 30 days after surgery, and 90-day survival rates will also be recorded.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older, male or female
- •Scheduled to perform major laparoscopic surgery under general anesthesia
- •Expected duration of surgery ≥ 2 hours
- •Written informed consent is obtainable either from the patient or from a legal surrogate
排除标准
- •BMI ≥ 35 kg/m
- •History of pulmonary surgery (of any type).
- •History of severe chronic obstructive pulmonary disease (COPD) requiring non-invasive ventilation and/or home oxygen therapy.
- •Patients on systemic corticosteroid treatment for acute chronic obstructive pulmonary disease exacerbation.
- •Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure > 40 mmHg.
- •Heart failure according to the New York Heart Association classification (class III or IV), ongoing hemodynamic instability, or severe shock (determined by the attending internist, cardiac index < 2.5 L/min/m2, or the requirement for positive inotropic drugs to maintain blood pressure).
- •Severe cardiac disease (acute coronary syndrome according to Canadian Cardiovascular Society, atrial flutter/fibrillation, sustained ventricular tachyarrhythmias, metabolic equivalent of tasks (METs) < 4) (METs < 4, determined by the inability to climb ≥ 2 flights of stairs).
- •Severe liver or renal dysfunction (Child-Pugh score 10-15, serum creatinine ≥ 2 mg/dL, or patients requiring peritoneal dialysis or hemodialysis).
- •Neuromuscular disease (of any type).
- •History of bone marrow transplantation or recent history of immunosuppressive drugs (chemotherapy or radiotherapy within 2 months before surgery).
- •Mechanical ventilation duration > 30 minutes within the past 30 days (e.g., surgery under general anesthesia).
- •Requirement for one-lung ventilation.
- •History of acute respiratory distress syndrome with potential need for prolonged postoperative mechanical ventilation.
- •Planned re-intubation after surgery.
- •Pregnancy (excluded by medical history and/or laboratory tests).
- •Brain injury or tumor.
- •Requirement for prone or lateral position during surgery.
- •Severe esophagogastric varices.
- •Enrollment in other interventional studies or refusal to sign informed consent.
结局指标
主要结局
postoperative pulmonary complications
时间窗: within 7 days after surgery
the incidence of postoperative pulmonary complications
次要结局
- airway peak pressure (cmH2O)(intraoperative)
- plateau pressure(intraoperative)
- positive end-expiratory pressure(intraoperative)
- esophageal pressure (Pes)(intraoperative)
- driving pressure (cmH2O)(intraoperative)
- dynamic lung compliance (mL/cmH20)(intraoperative)
- transpulmonary pressure (PL)(intraoperative)
- static compliance (mL/cmH20)(intraoperative)
- PaO2/FiO2 ratio(before surgery, intraoperative, and in post-anesthetic care unit)
- non-respiratory complications(within 7 days after surgery)
- QoR-15 scores(day 1 and day 7 after surgery, the day of discharge)
- unplanned reintubation(day 1 to day 7 after surgery)
- Interleukin-6 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- unplanned transfer to the ICU(day 1 to day 7 after surgery)
- angiopoietin-2 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- duration of ICU stay(day 1 after surgery to the day of discharge, assessed up to 90 days)
- length of hospital stay(from the day of admission to the day of discharge, assessed up to 90 days)
- Clara cell secretory protein-16 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- soluble receptor for advanced glycation end product level(before surgery, before the end of surgery and in post-anesthetic care unit)
- plasminogen activator inhibitor-1(before surgery, before the end of surgery and in post-anesthetic care unit)
- mortality rates(at 90 days after surgery)
- complications(at 30 days after surgery)
- vital signs(admission to operating room to day 7 after surgery, and the day of discharge)
- Vasoactive medications dosages(intraoperative)
- QoR-15 scores(day 1 and day 7 after surgery, the day of discharge)
- unplanned reintubation(day 1 to day 7 after surgery)
- unplanned transfer to the ICU(day 1 to day 7 after surgery)
- duration of ICU stay(day 1 after surgery to the day of discharge, assessed up to 90 days)
- airway peak pressure (cmH2O)(intraoperative)
- plateau pressure(intraoperative)
- positive end-expiratory pressure(intraoperative)
- esophageal pressure (Pes)(intraoperative)
- driving pressure (cmH2O)(intraoperative)
- transpulmonary pressure (PL)(intraoperative)
- dynamic lung compliance (mL/cmH20)(intraoperative)
- static compliance (mL/cmH20)(intraoperative)
- length of hospital stay(from the day of admission to the day of discharge, assessed up to 90 days)
- Interleukin-6 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- Clara cell secretory protein-16 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- soluble receptor for advanced glycation end product level(before surgery, before the end of surgery and in post-anesthetic care unit)
- angiopoietin-2 level(before surgery, before the end of surgery and in post-anesthetic care unit)
- plasminogen activator inhibitor-1(before surgery, before the end of surgery and in post-anesthetic care unit)
- mortality rates(at 90 days after surgery)
- complications(at 30 days after surgery)
- vital signs(admission to operating room to day 7 after surgery, and the day of discharge)
- PaO2/FiO2 ratio(before surgery, intraoperative, and in post-anesthetic care unit)
- non-respiratory complications(within 7 days after surgery)