Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]
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
- 否
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
Subhas Banerjee
Associate Professor of Medicine
Stanford University
