Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intraoperative mechanical power
研究概览
简要总结
The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
- •Had an intermediate risk of developing postoperative pulmonary complications.
- •Pulse oxygen saturation in room air ≥ 94%.
- •Aged 60 to 80 years.
排除标准
- •Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.
- •Had a history of pneumonia within 1 month prior to surgery.
- •Had severe chronic obstructive pulmonary disease or pulmonary bullae.
- •Had a progressive neuromuscular illness.
- •With an American Society of Anesthesiologists (ASA) physical status of IV or higher.
- •Intracranial hypertension.
- •Body mass index (BMI) ≥30 kg/m
- •Were involved in other interventional studies.
结局指标
主要结局
Intraoperative mechanical power
时间窗: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½\[Pplat - PEEP\] + \[Ppeak - Pplat\])
次要结局
- Surfactant Protein D (SP-D)(20 minutes after entering PACU)
- Mechanical power during capnoperitoneum(30 minutes after starting carbon dioxide pneumoperitoneum)
- Shunt fraction(Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery)
- Postoperative pulmonary complications score(Day 0 to 3 after surgery)
- Rate of need for vasoconstrictors(During intraoperative mechanical ventilation, an average of 3 hours)
- Soluble advanced glycation end products receptor (sRAGE)(20 minutes after entering PACU)
- Postoperative hospitalization days(Day 0 to 30 after surgery)
- Death from any cause(Day 0 to 30 after surgery)
- Rate of intraoperative hypotension(During intraoperative mechanical ventilation, an average of 3 hours)
- Rate of intraoperative bradycardia(During intraoperative mechanical ventilation, an average of 3 hours)
- Rate of respiratory failure at post-anesthesia care unit (PACU)(Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU)
- Rate of sustained hypoxaemia(Day 0 to 3 after surgery)
- Tumor Necrosis Factor alpha (TNF-α)(20 minutes after entering PACU)
- Accumulative mechanical power (AMP)(During intraoperative mechanical ventilation, an average of 3 hours)
- An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)(Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery)
- Dead space rate(Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery)
- Clara cell protein 16 (CC16)(20 minutes after entering PACU)
- Interleukin 6 (IL-6)(20 minutes after entering PACU)
- Rate of postoperative respiratory failure(Time Frame: Day 0 to 3 after surgery)
- Rate of pneumothorax(During surgery or within 7 days after surgery)
- Rate of pleural effusion(within 7 days after surgery)
- Unexpected admission to ICU(within 30 days after surgery)
- Rate of intraoperative hypoxemia(During intraoperative mechanical ventilation, an average of 3 hours)