Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,176
- 试验地点
- 16
- 主要终点
- Oxygenation Index
研究概览
简要总结
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.
详细描述
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged > 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.
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, Investigator, 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
- •Age not less than 65 years
- •American Society of Anesthesiologists grades I-III
- •No history of drug allergies or abnormal anesthesia.
- •The duration of mechanical ventilation was expected to be more than 2 hours.
- •Laparoscopic Gastrointestinal Surgery
- •The preoperative oxygen saturation was not less than 94%.
- •The patients will be planned to extubate in the operating room.
排除标准
- •History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
- •Cardiac function Class IV (New York Heart Association classification)
- •Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
- •Patients with blurred consciousness and cognitive dysfunction
- •Severe coagulation dysfunction.
- •Without preoperative oxygen inhalation, blood oxygen level <94%, and severe pulmonary dysfunction
- •Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.
- •Body mass index (BMI) >30kg/m2
- •Inability to complete the study
研究组 & 干预措施
Control: 80% Oxygen
Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. Blood will be collected for blood gas analysis within 48 hours after surgery.
干预措施: 80% Oxygen (Drug)
Experimental: 40% Oxygen
Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, FiO2 will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. However, when intraoperative oxygen saturation is less than 94%, the manual lung recruitment maneuver will also be performed. Patients should transfer to 80% Oxygen group if intraoperative oxygen saturation less than 85%.Blood will be collected for blood gas analysis within 48 hours after surgery.
干预措施: 40% Oxygen (Drug)
结局指标
主要结局
Oxygenation Index
时间窗: On the postoperative 48th hour
The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.
次要结局
- 30-day Mortality(On the postoperative 30th day)
- Lactic acid in blood gas analysis 48 hours after the operation(On the postoperative 48th hour)
- pH value in blood gas analysis 48 hours after the operation(On the postoperative 48th hour)
- oxygen uptake rate(On the postoperative 48 hour)
- inspired oxygen concentration(On the postoperative 48 hour)
- oxygen inhalation time(On the postoperative 48 hour)
- 7 days pulmonary complications(On the postoperative 7th day)
- PaCO2 in blood gas analysis 48 hours after the operation(On the postoperative 48th hour)
研究者
Wenfei Tan
Professor,Chairman
China Medical University, China