Effects of Different Inhalation Oxygen Concentrations on Oxygenation Index and Immediately Postoperative Atelectasis in Neurosurgery Patients. DIOCA-Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- the occurrence of atelectasis
研究概览
简要总结
This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position.
详细描述
This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position. A total of 96 neurosurgical patients under supine position were selected with an estimated operation time of more than 2 hours. Patients were randomly assigned to low-oxygen concentration (30%FiO2) L group, or high-oxygen concentration (60%FiO2) H group, and both groups received lung protective ventilation strategies. The main outcome was the comparison of postoperative atelectasis volume between the two groups. Secondary outcomes were the comparison of intraoperative oxygenation index and postoperative changes in diaphragm height between the two groups.
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)
盲法说明
In addition to the anesthesiologist on the day of surgery, the patients and all participants, statistical analysts, ward staff, surgeons, and treatment-outcome assessors are blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with American Society of Anesthesiologist (ASA) physical status I-II;
- •Older than 18 years; Patients with operation time more than 2 hours and plan to extubate in the operating room;
- •Preoperative blood gas partial pressure of oxygen was more than 80mmHg;
- •Patients scheduled for elective neurosurgery were operated in the supine position.
排除标准
- •A history of acute lung injury with acute respiratory distress syndrome within three months;
- •Heart failure (New York Heart Association class) greater than IV, severe liver and kidney dysfunction (Child B or C liver failure, glomerular filtration rate <30ml/min);
- •BMI > 30 kg/m
- •The operation time is more than 10 hours;
- •The amount of bleeding was more than 500ml; The total fluid volume exceeded 3000ml.
研究组 & 干预措施
Experimental: 30% Oxygen
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 30%, and the total gas flow rate will be set at 2L/min. 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, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.
干预措施: 30% Oxygen (Drug)
Placebo Comparator: 60% Oxygen
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 60%, and the total gas flow rate will be set at 2L/min. 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. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.
干预措施: 60% Oxygen (Drug)
结局指标
主要结局
the occurrence of atelectasis
时间窗: On the operating room within 40 minutes after awakening
The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening.
次要结局
- oxygenation index(On the operating room within 40 minutes after awakening)
- bilateral diaphragmatic muscles(On the operating room within 40 minutes after awakening)
研究者
Wenfei Tan
Professor
China Medical University, China