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临床试验/NCT05835661
NCT05835661招募中不适用

Nasopharyngeal Airway in Obese Patients Undergoing Painless Gastroenteroscopy Compared With Transnasopharyngeal Airway

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
246
试验地点
1
主要终点
Operating duration

研究概览

简要总结

Painless endoscopy is a popular endoscopic diagnosis and treatment method at present, and propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory center inhibition effect, leading to the decrease of blood oxygen saturation in patients, especially obese patients, more prone to blood oxygen plunge, even threatening life.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypoventilation may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, thus causing hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients.Currently, supracloglottic ventilation devices that have little impact on patients and are easy to accept are often used clinically to complete short daytime operations. The most common is the application of oropharyngeal ventilation to solve upper airway obstruction , however, oropharyngeal ventilation is inconvenient to use in gastroenteroscopy and treatment, while nasopharyngeal ventilation is suitable. However, based on the experience of observers,Although the nasopharyngeal airway can play a good role in the unobtrusived airway, the incidence of nasopharyngeal hemorrhage is high, and the comfort of patients is poor. Therefore, the researchers considered to directly insert the nasopharyngeal airway into the pharyngeal cavity next to the oral pad through the mouth, so as to achieve the effect of unobtrusived airway and increase the local oxygen concentration, and the idea of this experiment came from this.

详细描述

The purpose of this trial is to reduce complications, ensure safety during gastroenteroscopy and improve postoperative satisfaction of patients.According to the preliminary experimental results, the nasopharyngeal airway inserted by the oral pad is more convenient than the traditional operation, and the incidence of postoperative bleeding and pharyngeal pain is lower.The pros and cons of these two methods will be fully informed when the informed consent is signed with the patients at the early stage of the trial, so that the patients can voluntarily choose the implantation method.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Operating duration

时间窗: Intraoperative (From the insertion of nasopharyngeal airway to the adjustment of position under gastroscopy)

The period of time from the beginning of insertion of the nasopharyngeal airway until it is adjusted into place

The incidence of nasopharyngeal hemorrhage and postoperative pharyngeal pain

时间窗: The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery

The satisfaction survey was carried out in the resuscitation room after the recovery of the patients, and the adverse reactions such as bleeding and sore throat were asked

次要结局

  • The lowest drop in SPO2 during anesthesia(Intraoperative (From the beginning to the end of anesthesia))
  • Postoperative satisfaction of patients(The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery)

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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