跳至主要内容
临床试验/NCT04123821
NCT04123821已完成不适用

The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy: A Multi-center Randomized Controlled Trial

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2019年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
334
试验地点
1
主要终点
Incidence of Respiratory events (desaturation)

研究概览

简要总结

The goal of this prospective, multi-center, single-blinded randomized controlled trial is to assess the efficacy of NPA in reducing respiratory events in patients being admitted for GI endoscopy (colonoscopy, gastroscopy, endoscopic ultrasound) under deep sedation. The main question it aims to answer are: • [Is the NPA used on patients undergoing gastrointestinal endoscopy efficient in reducing respiratory events?] Participants will be randomly allocated into one of the two groups: NPA with 5L/min oxygen through nasal cannula (group A) or 5 L/min oxygen through nasal cannula alone (group B). Researchers will compare NPA group to nasal cannula group to see if the routine placement of an NPA can reduce the frequency of airway obstruction, hypoxemic events and airway maneuvers (chin lift, oral airway insertion, and mask-bag ventilation) during endoscopic sedation.

详细描述

Monitored anesthesia care (MAC) is currently the dominant method of endoscopic sedation for approximately one third of all US gastroenterologists. The popularity and success of MAC can be ascribed to many factors including increased patient turnover and improved patient satisfaction. Patients undergoing MAC maintain spontaneous breathing and routinely receive supplemental oxygen. In case of airway obstruction, additional airway adjuncts may be used such as supraglottic airway devices including oropharyngeal airway, nasopharyngeal airway, laryngeal mask, etc. A nasopharyngeal airway (NPA) is a simple device that can be conveniently inserted into the supraglottic airway to secure an open passage. This is a prospective, multi-center, single-blinded randomized controlled trial designed to evaluate the efficacy of the routine use of NPA in preventing airway obstruction during deep sedation. Patients undergoing gastrointestinal endoscopy under monitored anesthesia care using target-controlled infusion of propofol at AUBMC will be randomly and equally apportioned to the NPA (group A) or nasal cannula group (group B). Episodes of desaturation, airway maneuvers, hemodynamic instability, adverse events related to NPA insertion, duration of the procedure, and the anesthetic dose will be recorded. The satisfaction of the anesthesiologist, gastroenterologist, and patient will be scored. The aim of this study is first to assess the efficacy of NPA in reducing respiratory events, and second, to identify the safety of this device as well as patient, gastroenterologist and anesthesiologist satisfaction.

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
Double (Investigator, 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of Respiratory events (desaturation)

时间窗: During the procedure

oxygen saturation (%)

Incidence of Respiratory events (mask-bag ventilation)

时间窗: During the procedure

Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes

Incidence of Respiratory events (chin lift/jaw thrust)

时间窗: During the procedure

Occurrence of the event (chin lift/jaw thrust):yes or no and the number of episodes if yes

次要结局

  • Incidence of hypotension(During the procedure)
  • Satisfaction score of the patient(Up to 2 hours after the procedure)
  • Intubation(During the procedure)
  • Interruptions during the case(During the procedure)
  • Bradycardia(During the procedure)
  • Epistaxis(During the procedure)
  • Cough(During the procedure)
  • Laryngospasm(During the procedure)
  • Movement impeding procedure(During the procedure)
  • Satisfaction score of the anesthesiologist(Up to 2 hours after the procedure)
  • Satisfaction score of the proceduralist(Up to 2 hours after the procedure)

研究者

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

Christian Rouphael

Instructor of Clinical Specialty

American University of Beirut Medical Center

研究点 (1)

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