Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways:A Prospective Randomized Controlled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- The success of intubation for the first time
研究概览
简要总结
Purpose:
To compare the efficacy and safety of TCI tube core and ordinary tube core assisted tracheal intubation in simulating difficult airway under visual laryngoscope, and to provide reference for clinical application
详细描述
Endotracheal intubation plays an important role in contemporary clinical anesthesia. Direct laryngoscope intubation is the traditional intubation method in anesthesia and emergency medical work. However, due to the constraints of the operator's technical level, the abnormal airway structure and the condition of patients, about 1.5% ~ 8.5% of the cases of intubation difficulties occur. It's even impossible to intubate. Failure of intubation can lead to major complications, including brain damage and death. When a tracheal intubation cannot be placed on the first two attempts, the intubation is classified as difficult, and repeated routine tracheal intubation may lead to morbidity in the patient, and the incidence of airway related complications increases significantly with the number of tracheal intubations. Difficult intubation accounted for 4% of operating room intubation and 10% of intubation outside the operating room. For patients with high glottis and short epiglottis, although the glottis can be seen, intubation is difficult to place. The effectiveness and safety of TCI tube assisted intubation under visual laryngoscope and ordinary tube tube assisted intubation in simulated difficult airway were compared to provide reference for clinical application.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men ≥18 years of age or non-pregnant women;
- •For elective gynecological surgery or upper abdominal surgery under general anesthesia by oral tracheal intubation, the operation position was supine and the operation time was less than 3 hours;
- •Subject's American Society of Anesthesiologists physical status is I-III
- •Subjects who could understand the purpose of the trial, voluntarily participated and signed the informed consent form, and were willing to accept the designated follow-up.
排除标准
- •any cerebrovascular accident, such as stroke, transient ischemic attack (TIA), etc. occurred within 3 months;
- •patients with unstable angina pectoris or myocardial infarction within 3 months;
- •laryngeal mass, obstruction, maxillofacial fracture or deformity;
- •Full stomach, high intra-abdominal pressure, habitual vomiting, gastroesophageal reflux disease;
- •pharyngeal infection, hematoma, abscess, tonsil enlargement;
- •Upper respiratory tract infection within one month, fever, cough, runny nose, nasal congestion, etc.;
- •history of chronic airway inflammation, airway hyperresponsiveness or asthma;
- •diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
- •severe complications of hypertension, such as arterial dissection, renal failure, cerebral hemorrhage, etc.;
- •reoperation within 3 months;
- •patients with contraindications or allergies to intraoperative drugs;
- •patients enrolled in other studies within 30 days;
- •poor adherence or the investigator's opinion that the patient was not suitable for the study.
结局指标
主要结局
The success of intubation for the first time
时间窗: 1 day of surgery
To compare the success rate of first intubation in simulated difficult airway with TCI tube assisted by visual laryngoscope and ordinary tube.
次要结局
- Overall success rate of intubation(1 day of surgery)
- Whether it is necessary to rotate the tracheal tube through the glottis(1 day of surgery)
- Throat complications(24 hours after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital