Application of Protective Ventilation Improves Oxygenation During and After Anesthesia. Is it Possible That a Special Procedure, an Oxygenation Test, Can Replace Arterial Blood Gases When Evaluating Oxygenation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
研究概览
简要总结
The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.
Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.
Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective surgery of Morbid Obesity.
- •(ASA = American Society of Anesthesiologists classification).
- •"Body mass index" (BMI) ≥ 35 but < 50
排除标准
- •Anticipated difficult intubation.
- •Major bleeding.
- •Problems with ventilation necessitating protocol aberrations.
- •Obstructive sleep apnea syndrome with CPAP treatment at home.
- •Angina Pectoris
研究组 & 干预措施
Start O2 100% and CPAP 10, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with an inspiratory oxygen fraction(FIO2) of 1.0, supplied by a continuous positive airway pressure of 10 centimeters of water(cmH2O), during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled CPAP and 100% oxygen.
干预措施: CPAP and 100% oxygen (Procedure)
Start O2 100% and CPAP 10, end O2 31%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, supplied by a continuous positive airway pressure of 10 cmH2O, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 0.3 is used. The intervention associated with this arm is labeled CPAP and 31% oxygen.
干预措施: CPAP and 31% oxygen (Procedure)
Start O2 100% and CPAP 0, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, without a continuous positive airway pressure, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled No CPAP and 100% oxygen.
干预措施: No CPAP and 100% oxygen (Procedure)
结局指标
主要结局
Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
时间窗: Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.
During anesthesia SpO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 does not go lower than 87 % and compared to SpO2 immediately before anesthesia. SpO2 breathing air one hour after anesthesia is compared to SpO2 before anesthesia.
次要结局
- Arterial blood gas values for saturation (SaO2)(5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.)
- Arterial oxygen tension (PaO2)(5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.)
研究者
Lennart Edmark
Principal Investigator
Region Västmanland