High-flow Nasal Oxygenation Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- Minimum blood oxygen saturation (SpO2)
研究概览
简要总结
With the continuous strengthening of the concept of rapid rehabilitation, great progress has been made in minimally invasive thoracic surgery, and thoracoscopic surgery has developed rapidly. Double-lumen endotracheal(DLT) intubation is still the most reliable way of intubation in lung surgery. However, hypoxemia faced during double-lumen intubation still threatens the perioperative safety of thoracic surgery patients. In recent years, high-flow nasal oxygenation (HFNO) has great potential in the field of anesthesia, especially playing a new and important role in the prevention and treatment of short-term hypoxia and life-threatening airway emergencies. However, the use of HFNO in pulmonary surgery patients with poor pulmonary function lacks evidence-based basis, and there are few reliable clinical data.
This study adopted a prospective, randomized, controlled, single-blind design. A total of 100 patients aged 18-60 years who underwent elective thoracoscopy-assisted pulmonary surgery were included and randomly divided into the experimental group: HFNO was used in the process of double-lumen intubation asphyxia; the control group: according to the traditional intubation process, No oxygen therapy equipment was used during intubation asphyxiation. The lowest blood oxygen saturation during intubation, the incidence of hypoxemia during intubation, perioperative complications, and postoperative hospital stay were compared between the two groups.
This study explores the advantages of HFNO in complex endotracheal intubation, assuming that HFNO can improve the oxygen saturation of double-lumen intubation; optimize the intubation method of DLT, and tap its new potential to prevent and manage emergency airway crisis.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60;
- •Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation;
- •Patients who agreed to participate in this study.
排除标准
- •American Society of Anesthesiologists (ASA) classification > IV;
- •Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation;
- •Morbid obesity [Body Mass Index (BMI)>35kg/m2)];
- •Airway anatomical abnormalities;
- •Abnormal coagulation function;
- •Emergency surgery;
- •Patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease;
- •Pregnant or breastfeeding women.
结局指标
主要结局
Minimum blood oxygen saturation (SpO2)
时间窗: After the DLT intubation
Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
次要结局
- Operator satisfaction with intubation(After the DLT intubation)
- The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)(Up to 1 week)
- The incidence of lowest SpO2<90%(After the DLT intubation)
- Incidence of related complications during intubation(After the DLT intubation)
- The incidence of postoperative airway-related complications(1st, 2nd and 3rd day after surgery)
- End-tidal oxygen concentration after intubation(After the DLT intubation)
- The incidence of lowest SpO2<95%(After the DLT intubation)
- DLT intubation time(After the DLT intubation)
- End-tidal carbon dioxide partial pressure after intubation(After the DLT intubation)
- The incidence of difficult airway(After the DLT intubation)
- The incidence of bronchial dislocation(After the DLT intubation)
- The incidence of nausea and vomiting(1st, 2nd and 3rd day after surgery)
- Patient satisfaction with anesthesia(The first day after surgery)
- Postoperative hospital stay(Through study completion, an average of 4 weeks)
- The incidence of postoperative complication(Through study completion, an average of 4 weeks)