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临床试验/NCT03853239
NCT03853239Unknown不适用

A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Difference in expired tidal volume of each technique under pressure-controlled mode

研究概览

简要总结

Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults.

Forty patients were randomly assigned (sealed envelope method) to face mask(Group A,n=20)or nasal ventilation(Group B,n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-55 years old
  • ASA physical status I and II
  • Requiring general anesthesia with nasal intubation

排除标准

  • Respiratory disease,cardiovascular disease, cerebral vascular disease
  • Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring)
  • The need for emergency surgery
  • Contraindications to nasal intubation
  • Pregnancy
  • Gastric-esophageal reflex or a full stomach

结局指标

主要结局

Difference in expired tidal volume of each technique under pressure-controlled mode

时间窗: 3 breaths of expired tidal volume for each technique

Difference in air leakage of each technique under volume-controlled mode

时间窗: 3 breaths of air leakage for each technique

次要结局

  • number of participants with Oxygen Saturation- Reading Below 95%(intraoperative duration of each ventilation technique)
  • hemodynamic changes(intraoperative duration of each ventilation technique)
  • peak inspiratory pressure(intraoperative duration of each ventilation technique)
  • end tidal CO2 partial pressure Reading- Median(intraoperative duration of each ventilation technique)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Sun

Principal Investigator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

研究点 (1)

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Nasal Ventilation vs Face Mask | 临床试验