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临床试验/NCT06139081
NCT06139081已完成不适用

The Effect of Different Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With High Risk of Hypoxia During Painless Gastroscopy

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 648 人开始时间: 2023年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
648
试验地点
1
主要终点
Incidence of hypoxemia

研究概览

简要总结

In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.

详细描述

This study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. The control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: Before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. After the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. The incidence of intraoperative hypoxemia was observed.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:
  • •Patients combined with heart or respiratory diseases
  • •Age older than 60
  • •ASA grading II-III
  • •BMI≥30kg/m²,
  • •Snoring or having sleep apnea syndrome
  • •Patients with a STOP-Bang score ≥ 3 (the risk of OSAS is high) are considered to be highly risk of hypoxia.

排除标准

  • •Severe cardiovascular, pulmonary, liver, or kidney disease
  • •Patients with infections or tumors of airway
  • •History of difficult intubation under general anesthesia
  • •Severe sleep apnea syndrome [hypopnea/apnea hypopnea index (AHI)>40]
  • •Patients allergic to propofol, eggs, soy or egg whites

研究组 & 干预措施

Group B

No Intervention

Nasal catheter was used to give oxygen before, during and after withdrawal of gastroscope

Group A

Experimental

Transnasal oxygen was administered by nasal catheter before gastroscopy, transoral oxygen was administered by nasal catheter during gastroscopy, and transnasal oxygen was administered by nasal catheter after withdrawal of gastroscope.

干预措施: Oxygen delivery mode (Other)

结局指标

主要结局

Incidence of hypoxemia

时间窗: Five minutes after finishing gastroscopy examination

SpO2\<92%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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