NCT05556174已完成不适用
Intraoperative Lung Protective Ventilation With or Without Periodic Lung Recruitment Maneuvers on Pulmonary Complications After Major Abdominal Surgery: a Prospective Randomized Controlled Study
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,060 人开始时间: 2022年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Rate of respiratory failure
研究概览
简要总结
Postoperative Pulmonary Complications (PPC) are common. It severely affects postoperative recovery, particularly in abdominal surgery. Several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. Other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. The purpose of this study was to compare the effects of the above two regimens on 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h)
- •had an intermediate to high risk of developing postoperative pulmonary complications as indicated by an Assess Respiratory Risk in Surgical Patients in Catalonia score (≥26)
- •Pulse oxygen saturation in room air ≥ 94%
排除标准
- •younger than 18 years
- •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
- •severe heart dysfunction (New York Heart Association classification ≥4)
- •with an American Society of Anesthesiologists (ASA) physical status of IV or higher
- •Intracranial hypertension
- •were pregnant (excluded by laboratory analysis)
- •were involved in other interventional studies
结局指标
主要结局
Rate of respiratory failure
时间窗: Day 0 to 7 after surgery
Respiratory failure: postoperative arterial partial pressure of oxygen (PaO2) \< 8 kPa (60 mmHg) on room air, a PaO2: Inhaled oxygen concentration (FI02) ratio \< 40 kPa (300 mmHg) or arterial oxyhaemoglobin saturation measured with pulse oximetry \< 90% and requiring oxygen therapy
次要结局
- Rate of respiratory infections(Day 0 to 7 after surgery)
- Rate of pleural effusion(Day 0 to 7 after surgery)
- Rate of mild respiratory failure(Day 0 to 7 after surgery)
- Rate of moderate respiratory failure(Day 0 to 7 after surgery)
- Rate of sustained hypoxaemia(Day 0 to 7 after surgery)
- Rate of pneumonia(Day 0 to 7 after surgery)
- Rate of aspiration pneumonitis(Day 0 to 7 after surgery)
- Rate of pneumothorax(Intraoperative or day 0 to 7 after surgery)
- Rate of Acute Respiratory Distress Syndrome(Day 0 to 7 after surgery)
- Rate of severe respiratory failure(Day 0 to 7 after surgery)
- Rate of modified respiratory failure(Day 0 to 7 after surgery)
- Postoperative pulmonary complications score(Day 0 to 7 after surgery)
- Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)(Day 0 to 7 after surgery)
- Rate of death(Day 0 to 30 after surgery)
- Rate of intraoperative needing for vasoconstrictor(Intraoperative, period of mechanical ventilation)
- Intraoperative mechanical power(Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation)
- Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2(Day 0 to 7 after surgery)
- Rate of Systemic Inflammatory Response Syndrome (SIRS)(Day 0 to 7 after surgery)
- Rate of Intraoperative bradycardia(Intraoperative, period of mechanical ventilation)
- Postoperative hospitalization days(Day 0 to 30 after surgery)
- Rate of Unexpected admission to intensive care unit (ICU)(Day 0 to 30 after surgery)
- Rate of intraoperative hypotension(Intraoperative, period of mechanical ventilation)
- Rate of intraoperative hypoxemia(Intraoperative, period of mechanical ventilation)
- Rate of post-anesthesia care unit respiratory failure(Postoperative, during postanesthesia care unit)
- PaO2 / FI02(Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation)
研究者
研究点 (1)
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