The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, care givers and outcomes assessors are blinded. The investigator should not be included in the blind because they need to adjust the ventilator settings.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery.
- •American Society of Anesthesiologists (ASA) classification 1~3
排除标准
- •patients with heart failure (NYHA class III~IV)
- •patients who are having moderate obstructive lung disease or restrictive lung disease
- •Low DLCO (< 75%)
- •patients with brain disease history or increased ICP
- •patients with pulmonary hypertension (mean PAP>25mmHg)
- •patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
- •patients with pre-existing hypercapnia or metabolic acidosis
- •body mass index (BMI) > 30 kg/m2
- •patients who have had contralateral lung surgery
- •patients who cannot read explanation and consent form
- •patients who are pregnant
研究组 & 干预措施
group 40
In group 40, target PaCO2 is 40 during surgery
干预措施: group 40 (Other)
group 50
In group 50, target PaCO2 is 50 during surgery
干预措施: group 50 (Other)
group 60
In group 60, target PaCO2 is 60 during surgery
干预措施: group 60 (Other)
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: about 60 minutes after reaching to the target PaCO2 (T2)
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2
次要结局
- Post-op complication: oxygen therapy(first 2~7 days after surgery)
- Post-op complication: desaturation event(first 3 days after surgery)
- Post-op complication: hospitalized days(30 days after surgery)
- Post-op complication(30 days after surgery)
- Post-op complication: ICU days(30 days after surgery)
- Dead(30 days after surgery)