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临床试验/NCT04385511
NCT04385511Unknown不适用

Feasibility of Preoxygenation by Supraglottic Jet Ventilation Substituted for Mask Pressurized Ventilation Before Endotracheal Intubation:A Randomized Controlled Trail

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年5月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
alveolar oxygen tension(PaO2)

研究概览

简要总结

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

详细描述

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

The investigators randomly divided the patients into 2 groups:Group C and Group S.Patients in Group C will be preoxygenation with mask pressurized ventilation while patients in Group S with supraglottic jet ventilation by Wei NASAL JET(WNJ).The tracheal intubation will be done after the 3 minutes preoxygenation. The investigators will measure the PaCO2 before and after preoxygenation, and the investigators will take the stomach-ultrasonography to find if there are too much gas in the gastro. If pulse oximetry is lower than 95% during the preoxygenation, the investigators will adjust the position of the Wei NASAL JET(WNJ) or use the change the way that the investigators hold the mask or change the pressure of ventilation on the basis of the group.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for any surgery under general anesthesia
  • adults age range from 18-64 years old
  • American Society of Anesthesiologists Physical Status Classification (ASA class) I-II
  • voluntary participation in this clinical trail, signed informed consents

排除标准

  • patients with epistaxis, rhinostenosis, the episodes of rhinitis, severe gastroesophageal reflux disease, severe respiratory disease, severe cardiovascular and cerebrovascular disease
  • long-term use if anticoagulant drugs
  • can't cooperate with intervention
  • pulse oximetry <95% with normal respiration

结局指标

主要结局

alveolar oxygen tension(PaO2)

时间窗: baseline (before preoxygenation)

The results comes from blood gas analysis

次要结局

  • PaCO2(baseline (before preoxygenation))
  • gastric antrum cross section(baseline (before preoxygenation))
  • complications(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hansheng Liang

Principal Investigator

Peking University People's Hospital

研究点 (1)

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