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临床试验/NCT03879720
NCT03879720Unknown不适用

Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]

Stanford University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Time to Procedure Start

研究概览

简要总结

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

详细描述

Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.

At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.

We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing ERCP at Stanford University Medical Center

排除标准

  • Unable to consent
  • Contra-indication to general anesthesia

结局指标

主要结局

Time to Procedure Start

时间窗: up to 1 hour

Time from patient entry into procedure room to insertion of endoscope/start of procedure

次要结局

  • Intubation Time (time from 'ready to intubate', to 'tube confirmation')(up to 1 hour)
  • Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension(up to 20 minutes)
  • Time from removal of GI endoscope to exit from procedure room(up to 60 minutes)
  • Tooth/oropharyngeal trauma, skin/musculoskeletal trauma(up to 24 hours post-procedure)
  • Materials and facility fees(up to 24 hours post-procedure)
  • Patient positioning time(up to 1 hour)
  • Need for special positioning equipment(up to 20 minutes)
  • Staff required for patient positioning(up to 20 minutes)
  • Staff survey/assessment of ergonomic strain(up to 1 hour)

研究者

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

Subhas Banerjee

Associate Professor of Medicine

Stanford University

研究点 (2)

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