Effect of Different Oxygen Concentrations During the Recovery Period Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Incidence of hypoxemia
研究概览
简要总结
Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation.
However, even inhaling a short period of pure oxygen can cause absorptive atelectasis, and may even impair the effectiveness of intraoperative protective ventilation measures continuing to post-operative period. The purpose of this study is to determine whether 30% oxygen before extubation after abdominal surgery could reduce hypoxemia incidence after extubation during the recovery period or not, compared to 100% oxygen. 590 patients scheduled to abdominal surgeries, will be randomly assigned to receive 30% or 100% oxygen concentration from the end of surgery to extubation after general anesthesia in the post-anesthesia care unit. The incidence of hypoxemia (SpO2 < 90%) from extubation to leaving the post-anesthesia care unit (PACU) is the primary outcome.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 aged 18-65 years old, scheduled for elective abdominal surgery in general anesthesia with endotracheal intubation; ASA I-III grade; cardiac function 1-2 grade; 18 kg/m2 < BMI < 28 kg/m2; Preoperative SpO2 ≥ 94% without oxygen supplementation at rest; pre-anesthesia assessment shows no difficult airway, no difficulty with mask ventilation, no difficulty in intubation during tracheal insertion, and no difficulty in extubation as expected.
排除标准
- •Respiratory infection recently, or atelectasis, inflammation, fibrosis, or pleural effusion by chest CT preoperatively.
- •History thoracic surgery and fractures of the sternum or ribs, chest deformity, difficulty in raising both upper limbs, or scoliosis.
- •High risk of reflux aspiration. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis).
- •Limb movement disorders. Mask ventilation or intubation difficulty during anesthesia induction. Occurrence of severe allergy, massive bleeding, suspected pulmonary embolism, pulmonary edema, myocardial injury, or cardiopulmonary arrest during surgery.
- •Currently participating in other clinical studies, which may have an impact on this study.
- •Inability to cooperate well for mental disorder, or hypophrenia.
结局指标
主要结局
Incidence of hypoxemia
时间窗: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit
次要结局
- Length of postoperative stay(At hospital discharge)
- Score of lung ultrasound(At the day of surgery after tracheal extubation in the post-anesthesia care unit)
- Incidence of post operative pulmonary-related complications(Within 7 days after surgery)
- Incidence of severe hypoxemia(At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit)
- Arterial partial pressure of oxygen (PaO2)(At the day of surgery after tracheal extubation in the post-anesthesia care unit)
- Area of atelectasis shown on chest CT(At the day of surgery after tracheal extubation)
- Number of patients unplanned transfers to the ICU(30 days after surgery)
- Number of patients return to the hospital after discharge(30 days after surgery)
- Number of deaths(30 days after surgery)
- Number of patients with important organ disfunction after surgery, including arrhythmia, acute myocardial injury, heart failure, renal function injury, liver function injury, and cerebrovascular accident.(30 days after surgery)
研究者
SanQing Jin
Professor
Sixth Affiliated Hospital, Sun Yat-sen University